Cosmetic AcneDahliaNCT04045119
Effect of a Facial Cream Containing Cannabidiol and Hemp Oil on Skin Hydration and Acne-prone Skin
A study testing Topical Moisturizer in people with Cosmetic Acne, run by Avicanna Inc at 1 site in Colombia.
Trial summary
This research seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD and hemp oil on facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Acne
- What is being tested?
- Topical Moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2019to 2 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (i.e., over 18 years old) men or women.
- Oily or acne-prone skin as defined by self-assessment
- Accepts and signs the informed consent.
Who cannot join
- Pregnant or breast-feeding women
- Subjects with a chronic disease that requires medication
- Subjects with known diagnosis of cancer
- Smoking habit or alcohol consumption habit (i.e., once a day or more)
- Recreational or medicinal use of cannabinoids
- Skin diseases (i.e., diseases that require care of a dermatologist)
Show all 11Show fewer
- Current medication uses such as: Immunomodulators, antibiotics, corticoids or retinoids
- Hypersensitivity to any component of the research product
- Involvement in other clinical or cosmetic studies in the last 6 months
- Recent exposure to sun causing sun tanning (i.e., as reported by the subject causing discomfort or change in the usual appearance of the skin)
- Permanent decoration of the skin in the test area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Facial Cream Containing 0.5% Cannabidiol and 0.1% Hemp Oil on Skin Hydration and Characteristics Associated Acne-prone Skin
This research seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD and hemp oil on facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.
Read the detailed description
In this research effort, hypothesis is that application of the topical product improves skin hydration as measured instrumentally by its electric properties as well as other variables associated with skin hydration, sebum production and appearance. Therefore, this research effort seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD, rosemary extract and hemp oil on facial skin. For this purpose, objective measures aimed at stablishing the change of parameters related to skin water content will be measured. Additionally, other measurements will be obtained to establish the change of different parameters related to the effect on appearance, instrumentally measured sebum production and quality of life. These include: instrumental and subjective measurement of oily skin and standardized photography for assessment of imperfections as well as, a validated assessment of the impact of acne-prone skin on quality of life.
Healthy adults will be invited to participate and the general characteristics of the product will be explained, as well as the amount of time that will be required. The individuals that agree to participate will have to read and sign the informed consent, register contact information, and will be scheduled for visit 0 at the research center within 2 to 7 days. During this period (i.e., washout period), the subject will be told not to use abrasive cleansing products or topical medicines on the facial skin, not to take more than one shower per day, and not to consume caffeine or alcohol 24 hours before attending the research center.
During the washout period the subject will receive a call to confirm compliance with washout requirements as well as visit 0 schedule. If washout conditions are not met, subject will be reminded to comply and visit will be re-scheduled within 2 to 7 days.
In visit 0 at the research center, contact information, demographic variables and standard anthropometric variables will be recorded. Subsequently, the subject will be given detailed information about the research product and protocol, accompanied by an information leaflet with indications regarding the use of the investigational product as well as recommendations on preferred hygiene regimens.
The subject will be able to review the material in a room under controlled ventilation, temperature, humidity and lighting conditions, where he or she will have to stay for a minimum of 30 minutes. After that, in an adjacent room under the same conditions, the basal characteristics of the facial skin will be measured through electrical and photometric variables as well as self-assessment of oily skin, a standardized photograph with visual assessment and self-image questionnaire (i.e., hour 0). The bioengineering measurements will be made on the cheeks (i.e., between the base of the ear lobe and the apex of the chin) and forehead (i.e., exact center of the forehead) and no marking of the measurement area will be performed.
Once this process is done, the subject goes back to the waiting room, where a research assistant explains how to apply the investigational product on the face and evaluate the product characteristics. The subject applies the product and evaluates its characteristics. 10 minutes after application, the subject will complete a perception survey about the product characteristics sensation produced on the skin. Afterwards, the subject may leave the room under controlled conditions; however, he or she must return 30 minutes prior to the next measurements.
One hour after the application of the topical product (including 30 minutes of acclimatization in the room under controlled conditions), a new measurement of the electrical, photometric and colorimetric variables as well as self-assessment of oily skin and a standardized photograph with visual assessment is made. This procedure is repeated after 3 hours (including 30 minutes of acclimatization in the room under controlled conditions). Once the last measurement is made the subject completes the last part of the survey and is given a vessel containing the investigational product and instructions regarding its usage will be reinforced. Additionally, schedule for next visit will be determined at this time.
The subject must apply the product according to the indications and keep a journal of the applications. Additionally, the subject must refrain from using other topical products on the volar forearm or systemic products that may alter the skin conditions. Furthermore, there will be a follow-up call to remind the participant to comply with the requirements and confirm schedule next visit.
Two weeks after visit 0, the subject will return to the research center, where a new measurement of the electrical, photometric and colorimetric variables as well as self-assessment of oily skin, a standardized photograph with visual assessment and self-image questionnaire is made. This procedure is repeated by the 4th week, additionally, the subject will answer the last part of the perception survey in this visit. Once this is completed the product application phase will be terminated and the amount of remaining product as well as any significant journal entries will be registered at this point.
Throughout the study there will be tolerance and safety monitoring in every visit and follow-up call, as follows: Upon first application of the investigational product there will be an observation of the subject during a 15-minute period done by the research staff, a physician will be available to assess any possible allergic reaction or significant irritation.
The research staff will examine the application site of the research product to find potential local reactions and will ask about any systemic symptom. If no adverse reactions occur, the information will be recorded. Similarly, if any adverse reaction, systemic reaction or adverse event occurs it will be recorded and the physician will take the necessary measures to ensure subject safety according to his expert judgement and initiate event reporting according to applicable regulation. Finally, in every phone call made by the call center, adherence and tolerance questions will be made and recorded.
At the 5th week, the subject will receive a final follow-up call to record any events that might have appeared after removing the product, thus ending follow-up phase
- Conditions
- Cosmetic Acne
- Being tested
- Topical Moisturizer
- Keywords
- CBD, Cosmetics, Acne-prone skin, Oily Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical MoisturizerOther
The investigational product is a moisturizing facial cream for skin with imperfections that is applied topically and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at improving skin hydration and characteristics associated acne-prone skin. The moisturizer also contains 0.1% of hemp oil rich in essential fatty acids and antioxidants and 0.5% of cannabidiol with regulatory effect on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Before-and-after | Experimental | 54 Healthy adults 18 years of age or older at the visit or will receive the first application and will be evaluated according to the objectives defined in the study (short-term data) and to evaluate the longterm effects, two other visits will be made at intervals of 2 weeks to evaluate the impact of topical skin application according to the parameters defined in the study Receives: Other: Topical Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect on hydration of a single application of the topical preparation on facial skin
Evaluate the effect on hydration of a single application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 1 and 3 hours. Measurement of the water content of the stratum corneum by capacitance.
Measured: Change from baseline at 1 and 3 hours
Evaluate the effect on hydration of periodic application of the topical preparation on facial skin
Evaluate the effect on hydration of periodic application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 2 and 4 weeks. Measurement of the water content of the stratum corneum by capacitance.
Measured: Change from baseline at 2 and 4 weeks
Secondary outcomes (11)
Evaluate the short-term change in instrumentally assessed measurement of oily skin
Evaluate the short-term change in instrumentally assessed measurement of oily skin (i.e., 1 and 3 hours), through photometrical transparency change of a translucent plastic strip.
Measured: Change from baseline at 1 and 3 hours
Evaluate the long-term change in instrumentally assessed measurement of oily skin
Evaluate the long-term change in instrumentally assessed measurement of oily skin (i.e., 2 and 4 weeks), through photometrical transparency change of a translucent plastic strip.
Measured: Change from baseline at 2 and 4 weeks
Evaluate the short-term change in instrumentally measured skin biochromophores
Evaluate the short-term change in instrumentally measured skin biochromophores (i.e., 1 and 3 hours)
Measured: Change from baseline at 1 and 3 hours
Evaluate the long-term change in instrumentally measured skin biochromophores
Evaluate the long-term change in instrumentally measured skin biochromophores (i.e., 2 and 4 weeks)
Measured: Change from baseline at 2 and 4 weeks
Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin
Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin, through the application of a validated questionnaire. Subjects will evaluate the degree of oiliness in a visual analog scale of 0 to 10 (i.e., 0: normal skin; 10: very severe oiliness)
Measured: Change from baseline at 1 and 3 hours
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin, through the application of a validated questionnaire Subjects will evaluate the degree of oiliness in a visual analog scale of 0 to 10 (i.e., 0: normal skin; 10: very severe oiliness)
Measured: Change from baseline at 2 and 4 weeks
Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance
Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance, trough standardized photography and investigator evaluation. Subjects will be assessed by the investigation staff in comparison with baseline as follows: Almost clear if 90-99% clearance is observed Marked improvement if 75-89% clearance is observed Moderate improvement if 50-74% clearance is observed Minimal improvement if 25-49% clearance is observed No change if 0-24% clearance from baseline is observed
Measured: Change from baseline at 1 and 3 hours
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance, trough standardized photography and investigator evaluation. Subjects will be assessed by the investigation staff in comparison with baseline as follows: Almost clear if 90-99% clearance is observed Marked improvement if 75-89% clearance is observed Moderate improvement if 50-74% clearance is observed Minimal improvement if 25-49% clearance is observed No change if 0-24% clearance from baseline is observed
Measured: Change from baseline at 2 and 4 weeks
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life, through the application of a standardized self-image questionnaire. The OSSIQ questionnaire will be used to perform self-image assessment by the subject using a five-point scale (never 0, rarely 1, sometimes 2, often 3, and always 4) to score 18 questions.
Measured: Change from baseline at 2 and 4 weeks
Evaluate the short and long-term emollient effect and acceptance of this topical preparation
Evaluate the short and long-term emollient effect and acceptance of this topical preparation, through the application of a perception survey (i.e., 0 hours, 1 hours and 4 weeks). Perceived skinfeel attributes of creams and lotions (appearance, rub-in, absorption, appearance of skin, immediate and delayed after-feel) have been evaluated using a trained descriptive panel. In previously published studies researchers used the skinfeel spectrum descriptive analysis method to characterize skin care products. They used strict protocols for manipulation and precisely defined terms to describe the qualitative properties and their relative intensities in each product. The evaluation process was divided into four categories: pick-up (i.e., firmness, stickiness, cohesiveness, peaking); rub-out (i.e., wetness, spreadability, thickness, absorbency); residual feel; and appearance, immediate and after 20 minutes (i.e., glossy, sticky, slippery, oily, waxy, greasy
Measured: 0 hours, 1 hour, and 4 weeks
Evaluate the short and long-term tolerance of this topical preparation
Evaluate the short and long-term tolerance of this topical preparation, through the application of a perception survey. This is scored by investigators using a four-point scale: absent, mild, moderate and severe.
Measured: 0 hours, 1 hour, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Oct 2019
- Primary completion2 Jan 2020
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cosmetic AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a quasi-experimental (i.e., prospective, non-randomized, non-controlled), open label trial
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avicanna Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria A Granados, MD., MSc., Principal investigator, Centro de Atencion e Investigacion Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045119
- Sponsor's protocol ID
- Av 0002 DaCol
- Acronym
- Dahlia
- Status last verified
- Apr 2020
- First submitted
- 1 Aug 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kapoor S, Saraf S. Assessment of viscoelasticity and hydration effect of herbal moisturizers using bioengineering techniques. Pharmacogn Mag. 2010 Oct;6(24):298-304. doi: 10.4103/0973-1296.71797.
PubMed 21120032Poli F, Dreno B, Verschoore M. An epidemiological study of acne in female adults: results of a survey conducted in France. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):541-5. doi: 10.1046/j.1468-3083.2001.00357.x.
PubMed 11843213Arbuckle R, Clark M, Harness J, Bonner N, Scott J, Draelos Z, Rizer R, Yeh Y, Copley-Merriman K. Item reduction and psychometric validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS). Value Health. 2009 Jul-Aug;12(5):828-37. doi: 10.1111/j.1524-4733.2009.00504.x.
PubMed 19508666Segot-Chicq E, Compan-Zaouati D, Wolkenstein P, Consoli S, Rodary C, Delvigne V, Guillou V, Poli F. Development and validation of a questionnaire to evaluate how a cosmetic product for oily skin is able to improve well-being in women. J Eur Acad Dermatol Venereol. 2007 Oct;21(9):1181-6. doi: 10.1111/j.1468-3083.2007.02193.x.
PubMed 17894702Biro T, Toth BI, Hasko G, Paus R, Pacher P. The endocannabinoid system of the skin in health and disease: novel perspectives and therapeutic opportunities. Trends Pharmacol Sci. 2009 Aug;30(8):411-20. doi: 10.1016/j.tips.2009.05.004. Epub 2009 Jul 14.
PubMed 19608284Kupczyk P, Reich A, Szepietowski JC. Cannabinoid system in the skin - a possible target for future therapies in dermatology. Exp Dermatol. 2009 Aug;18(8):669-79. doi: 10.1111/j.1600-0625.2009.00923.x.
PubMed 19664006Citti C, Pacchetti B, Vandelli MA, Forni F, Cannazza G. Analysis of cannabinoids in commercial hemp seed oil and decarboxylation kinetics studies of cannabidiolic acid (CBDA). J Pharm Biomed Anal. 2018 Feb 5;149:532-540. doi: 10.1016/j.jpba.2017.11.044. Epub 2017 Nov 20.
PubMed 29182999Mikulcova V, Kasparkova V, Humpolicek P, Bunkova L. Formulation, Characterization and Properties of Hemp Seed Oil and Its Emulsions. Molecules. 2017 Apr 27;22(5):700. doi: 10.3390/molecules22050700.
PubMed 28448475Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003 Feb;12(1):47-52. doi: 10.1136/qhc.12.1.47.
PubMed 12571345Tsai TH, Chuang LT, Lien TJ, Liing YR, Chen WY, Tsai PJ. Rosmarinus officinalis extract suppresses Propionibacterium acnes-induced inflammatory responses. J Med Food. 2013 Apr;16(4):324-33. doi: 10.1089/jmf.2012.2577. Epub 2013 Mar 20.
PubMed 23514231Rawlings AV, Canestrari DA, Dobkowski B. Moisturizer technology versus clinical performance. Dermatol Ther. 2004;17 Suppl 1:49-56. doi: 10.1111/j.1396-0296.2004.04s1006.x.
PubMed 14728699Petry T, Bury D, Fautz R, Hauser M, Huber B, Markowetz A, Mishra S, Rettinger K, Schuh W, Teichert T. Review of data on the dermal penetration of mineral oils and waxes used in cosmetic applications. Toxicol Lett. 2017 Oct 5;280:70-78. doi: 10.1016/j.toxlet.2017.07.899. Epub 2017 Aug 5.
PubMed 28789996Reuter J, Merfort I, Schempp CM. Botanicals in dermatology: an evidence-based review. Am J Clin Dermatol. 2010;11(4):247-67. doi: 10.2165/11533220-000000000-00000.
PubMed 20509719Iffland K, Grotenhermen F. An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies. Cannabis Cannabinoid Res. 2017 Jun 1;2(1):139-154. doi: 10.1089/can.2016.0034. eCollection 2017.
PubMed 28861514Darlenski R, Sassning S, Tsankov N, Fluhr JW. Non-invasive in vivo methods for investigation of the skin barrier physical properties. Eur J Pharm Biopharm. 2009 Jun;72(2):295-303. doi: 10.1016/j.ejpb.2008.11.013. Epub 2008 Dec 11.
PubMed 19118626
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Facial Cream Containing 0.5% Cannabidiol and 0.1% Hemp Oil on Skin Hydration and Characteristics Associated Acne-prone Skin
- ClinicalTrials.gov ID
- NCT04045119
- Acronym / sponsor ID
- Dahlia / Av 0002 DaCol
- Conditions
- Cosmetic Acne
- Keywords
- CBD, Cosmetics, Acne-prone skin, Oily Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Avicanna IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD and hemp oil on facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.
Detailed description
In this research effort, hypothesis is that application of the topical product improves skin hydration as measured instrumentally by its electric properties as well as other variables associated with skin hydration, sebum production and appearance. Therefore, this research effort seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD, rosemary extract and hemp oil on facial skin. For this purpose, objective measures aimed at stablishing the change of parameters related to skin water content will be measured. Additionally, other measurements will be obtained to establish the change of different parameters related to the effect on appearance, instrumentally measured sebum production and quality of life. These include: instrumental and subjective measurement of oily skin and standardized photography for assessment of imperfections as well as, a validated assessment of the impact of acne-prone skin on quality of life.
Healthy adults will be invited to participate and the general characteristics of the product will be explained, as well as the amount of time that will be required. The individuals that agree to participate will have to read and sign the informed consent, register contact information, and will be scheduled for visit 0 at the research center within 2 to 7 days. During this period (i.e., washout period), the subject will be told not to use abrasive cleansing products or topical medicines on the facial skin, not to take more than one shower per day, and not to consume caffeine or alcohol 24 hours before attending the research center.
During the washout period the subject will receive a call to confirm compliance with washout requirements as well as visit 0 schedule. If washout conditions are not met, subject will be reminded to comply and visit will be re-scheduled within 2 to 7 days.
In visit 0 at the research center, contact information, demographic variables and standard anthropometric variables will be recorded. Subsequently, the subject will be given detailed information about the research product and protocol, accompanied by an information leaflet with indications regarding the use of the investigational product as well as recommendations on preferred hygiene regimens.
The subject will be able to review the material in a room under controlled ventilation, temperature, humidity and lighting conditions, where he or she will have to stay for a minimum of 30 minutes. After that, in an adjacent room under the same conditions, the basal characteristics of the facial skin will be measured through electrical and photometric variables as well as self-assessment of oily skin, a standardized photograph with visual assessment and self-image questionnaire (i.e., hour 0). The bioengineering measurements will be made on the cheeks (i.e., between the base of the ear lobe and the apex of the chin) and forehead (i.e., exact center of the forehead) and no marking of the measurement area will be performed.
Once this process is done, the subject goes back to the waiting room, where a research assistant explains how to apply the investigational product on the face and evaluate the product characteristics. The subject applies the product and evaluates its characteristics. 10 minutes after application, the subject will complete a perception survey about the product characteristics sensation produced on the skin. Afterwards, the subject may leave the room under controlled conditions; however, he or she must return 30 minutes prior to the next measurements.
One hour after the application of the topical product (including 30 minutes of acclimatization in the room under controlled conditions), a new measurement of the electrical, photometric and colorimetric variables as well as self-assessment of oily skin and a standardized photograph with visual assessment is made. This procedure is repeated after 3 hours (including 30 minutes of acclimatization in the room under controlled conditions). Once the last measurement is made the subject completes the last part of the survey and is given a vessel containing the investigational product and instructions regarding its usage will be reinforced. Additionally, schedule for next visit will be determined at this time.
The subject must apply the product according to the indications and keep a journal of the applications. Additionally, the subject must refrain from using other topical products on the volar forearm or systemic products that may alter the skin conditions. Furthermore, there will be a follow-up call to remind the participant to comply with the requirements and confirm schedule next visit.
Two weeks after visit 0, the subject will return to the research center, where a new measurement of the electrical, photometric and colorimetric variables as well as self-assessment of oily skin, a standardized photograph with visual assessment and self-image questionnaire is made. This procedure is repeated by the 4th week, additionally, the subject will answer the last part of the perception survey in this visit. Once this is completed the product application phase will be terminated and the amount of remaining product as well as any significant journal entries will be registered at this point.
Throughout the study there will be tolerance and safety monitoring in every visit and follow-up call, as follows: Upon first application of the investigational product there will be an observation of the subject during a 15-minute period done by the research staff, a physician will be available to assess any possible allergic reaction or significant irritation.
The research staff will examine the application site of the research product to find potential local reactions and will ask about any systemic symptom. If no adverse reactions occur, the information will be recorded. Similarly, if any adverse reaction, systemic reaction or adverse event occurs it will be recorded and the physician will take the necessary measures to ensure subject safety according to his expert judgement and initiate event reporting according to applicable regulation. Finally, in every phone call made by the call center, adherence and tolerance questions will be made and recorded.
At the 5th week, the subject will receive a final follow-up call to record any events that might have appeared after removing the product, thus ending follow-up phase
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a quasi-experimental (i.e., prospective, non-randomized, non-controlled), open label trial
| Arm | Type | Receives |
|---|---|---|
| Before-and-after | Experimental | Other: Topical Moisturizer54 Healthy adults 18 years of age or older at the visit or will receive the first application and will be evaluated according to the objectives defined in the study (short-term data) and to evaluate the longterm effects, two other visits will be made at intervals of 2 weeks to evaluate the impact of topical skin application according to the parameters defined in the study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (i.e., over 18 years old) men or women.
- Oily or acne-prone skin as defined by self-assessment
- Accepts and signs the informed consent.
Key exclusion criteria (11 listed)
- Pregnant or breast-feeding women
- Subjects with a chronic disease that requires medication
- Subjects with known diagnosis of cancer
- Smoking habit or alcohol consumption habit (i.e., once a day or more)
- Recreational or medicinal use of cannabinoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical MoisturizerThe investigational product is a moisturizing facial cream for skin with imperfections that is applied topically and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at improving skin hydration and characteristics associated acne-prone skin. The moisturizer also contains 0.1% of hemp oil rich in essential fatty acids and antioxidants and 0.5% of cannabidiol with regulatory effect on the skin. | Other | Before-and-after |
Primary outcome
Evaluate the effect on hydration of a single application of the topical preparation on facial skin
Time frame: Change from baseline at 1 and 3 hours
Evaluate the effect on hydration of a single application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 1 and 3 hours. Measurement of the water content of the stratum corneum by capacitance.
Evaluate the effect on hydration of periodic application of the topical preparation on facial skin
Time frame: Change from baseline at 2 and 4 weeks
Evaluate the effect on hydration of periodic application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 2 and 4 weeks. Measurement of the water content of the stratum corneum by capacitance.
11 secondary outcomes
Evaluate the short-term change in instrumentally assessed measurement of oily skin
Time frame: Change from baseline at 1 and 3 hours
Evaluate the long-term change in instrumentally assessed measurement of oily skin
Time frame: Change from baseline at 2 and 4 weeks
Evaluate the short-term change in instrumentally measured skin biochromophores
Time frame: Change from baseline at 1 and 3 hours
Evaluate the long-term change in instrumentally measured skin biochromophores
Time frame: Change from baseline at 2 and 4 weeks
Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin
Time frame: Change from baseline at 1 and 3 hours
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin
Time frame: Change from baseline at 2 and 4 weeks
Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance
Time frame: Change from baseline at 1 and 3 hours
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance
Time frame: Change from baseline at 2 and 4 weeks
Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life
Time frame: Change from baseline at 2 and 4 weeks
Evaluate the short and long-term emollient effect and acceptance of this topical preparation
Time frame: 0 hours, 1 hour, and 4 weeks
Evaluate the short and long-term tolerance of this topical preparation
Time frame: 0 hours, 1 hour, and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 21120032Kapoor S, Saraf S. Assessment of viscoelasticity and hydration effect of herbal moisturizers using bioengineering techniques. Pharmacogn Mag. 2010 Oct;6(24):298-304. doi: 10.4103/0973-1296.71797.
- Background: PubMed 11843213Poli F, Dreno B, Verschoore M. An epidemiological study of acne in female adults: results of a survey conducted in France. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):541-5. doi: 10.1046/j.1468-3083.2001.00357.x.
- Background: PubMed 19508666Arbuckle R, Clark M, Harness J, Bonner N, Scott J, Draelos Z, Rizer R, Yeh Y, Copley-Merriman K. Item reduction and psychometric validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS). Value Health. 2009 Jul-Aug;12(5):828-37. doi: 10.1111/j.1524-4733.2009.00504.x.
- Background: PubMed 17894702Segot-Chicq E, Compan-Zaouati D, Wolkenstein P, Consoli S, Rodary C, Delvigne V, Guillou V, Poli F. Development and validation of a questionnaire to evaluate how a cosmetic product for oily skin is able to improve well-being in women. J Eur Acad Dermatol Venereol. 2007 Oct;21(9):1181-6. doi: 10.1111/j.1468-3083.2007.02193.x.
- Background: PubMed 19608284Biro T, Toth BI, Hasko G, Paus R, Pacher P. The endocannabinoid system of the skin in health and disease: novel perspectives and therapeutic opportunities. Trends Pharmacol Sci. 2009 Aug;30(8):411-20. doi: 10.1016/j.tips.2009.05.004. Epub 2009 Jul 14.
- Background: PubMed 19664006Kupczyk P, Reich A, Szepietowski JC. Cannabinoid system in the skin - a possible target for future therapies in dermatology. Exp Dermatol. 2009 Aug;18(8):669-79. doi: 10.1111/j.1600-0625.2009.00923.x.
- Background: PubMed 29182999Citti C, Pacchetti B, Vandelli MA, Forni F, Cannazza G. Analysis of cannabinoids in commercial hemp seed oil and decarboxylation kinetics studies of cannabidiolic acid (CBDA). J Pharm Biomed Anal. 2018 Feb 5;149:532-540. doi: 10.1016/j.jpba.2017.11.044. Epub 2017 Nov 20.
- Background: PubMed 28448475Mikulcova V, Kasparkova V, Humpolicek P, Bunkova L. Formulation, Characterization and Properties of Hemp Seed Oil and Its Emulsions. Molecules. 2017 Apr 27;22(5):700. doi: 10.3390/molecules22050700.
- Background: PubMed 12571345Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003 Feb;12(1):47-52. doi: 10.1136/qhc.12.1.47.
- Background: PubMed 23514231Tsai TH, Chuang LT, Lien TJ, Liing YR, Chen WY, Tsai PJ. Rosmarinus officinalis extract suppresses Propionibacterium acnes-induced inflammatory responses. J Med Food. 2013 Apr;16(4):324-33. doi: 10.1089/jmf.2012.2577. Epub 2013 Mar 20.
- Background: PubMed 14728699Rawlings AV, Canestrari DA, Dobkowski B. Moisturizer technology versus clinical performance. Dermatol Ther. 2004;17 Suppl 1:49-56. doi: 10.1111/j.1396-0296.2004.04s1006.x.
- Background: PubMed 28789996Petry T, Bury D, Fautz R, Hauser M, Huber B, Markowetz A, Mishra S, Rettinger K, Schuh W, Teichert T. Review of data on the dermal penetration of mineral oils and waxes used in cosmetic applications. Toxicol Lett. 2017 Oct 5;280:70-78. doi: 10.1016/j.toxlet.2017.07.899. Epub 2017 Aug 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria A Granados, MD., MSc. principal investigator
Centro de Atencion e Investigacion Medica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Moisturizer in people with Cosmetic Acne, run by Avicanna Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect on hydration of a single application of the topical preparation on facial skin (time frame: Change from baseline at 1 and 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045119, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.