HealthyPhase 3NCT02241161
Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations
A Phase 3 study testing plantaricin a - rejuvenating cream, plantaricin a - antioxidant serum and plantaricin a - rejuvenating serum in people with Healthy, run by Derming SRL at 1 site in Italy.
Trial summary
Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- plantaricin a - rejuvenating cream, plantaricin a - antioxidant serum and plantaricin a - rejuvenating serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Dec 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers of both sexes, aged more than 18 years old
- Volunteers in a good general state of health in the Investigator opinion
- Volunteers not taking drugs or undergoing surgical procedure
- Volunteers who are giving a written informed consent.
Who cannot join
- Pregnancy (only for female subjects)
- lactation (only for female subjects)
- change in the normal habits in the last month
- participation in a similar study during the previous month
- known allergy to one or several ingredients of the products on trial
- insufficient adhesion to the study protocol
Show all 21Show fewer
- dermatological disease
- clinical and significant skin condition on the test area (e.g. lesions, scars, malformations)
- diabetes
- endocrine disease
- hepatic, renal or cardiac disorder
- cancer
- topical drugs or surgical procedure on the test areas during the previous 3 months
- systemic corticosteroids
- aspirin or non-steroid anti-inflammatory drugs (FANS)
- diuretic drugs
- antibiotics and chemotherapics
- pshycotropic drugs
- retinoids
- psoralens
- cardiologic and vascular drugs
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following three cosmetic products and the relative combinations (cream and serum) were assessed: rejuvenating cream, rejuvenating serum, antioxidant serum
- Conditions
- Healthy
- Being tested
- plantaricin a - rejuvenating cream, plantaricin a - antioxidant serum, plantaricin a - rejuvenating serum
- Keywords
- skin eythema, rejuvenating cream, rejuvenating serum, antioxidant serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantaricin a - rejuvenating creamOther
single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
plantaricin a - antioxidant serumOther
single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
plantaricin a - rejuvenating serumOther
single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| plantaricin a - rejuvenating cream | Active comparator | single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes Receives: Other: plantaricin a - rejuvenating cream |
| plantaricin a - rejuvenating serum | Active comparator | single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes Receives: Other: plantaricin a - rejuvenating serum |
| plantaricin a - antioxidant serum | Active comparator | single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes Receives: Other: plantaricin a - antioxidant serum |
| plantaricin a (rejuvenating cream +rejuvenating serum) | Active comparator | single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes Receives: Other: plantaricin a - rejuvenating cream; Other: plantaricin a - rejuvenating serum |
| plantaricin a (rejuvenating cream + antioxidant serum) | Active comparator | single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes Receives: Other: plantaricin a - rejuvenating cream; Other: plantaricin a - antioxidant serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0)
Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)
Measured: After 1 (T1h) hour from products application
Secondary outcomes (8)
Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0)
Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)
Measured: After 6 (T6h) hours from products application
Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0)
Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)
Measured: After 24 (T24h) hours from products application
Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0)
The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan
Measured: After 1 (T1h) hour from products application
Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0)
The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan
Measured: After 6 (T6h) hours from products application
Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0)
The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan
Measured: After 24 (T24h) hours from products application
Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0)
Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.
Measured: After 1 (Th1) hour from products application
Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0)
Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.
Measured: After 6 (T6h) hours from products application
Surface microrelief evaluation: change from baseline, after 24 hours from products application (T24h) hours from products application vs.T0)
Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.
Measured: After 24 hours (T24h) from products application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adele Sparavigna, Doctor, Principal investigator, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241161
- Sponsor's protocol ID
- E2913
- Status last verified
- Mar 2014
- First submitted
- 18 Jul 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buonocore D, Lazzeretti A, Tocabens P, Nobile V, Cestone E, Santin G, Bottone MG, Marzatico F. Resveratrol-procyanidin blend: nutraceutical and antiaging efficacy evaluated in a placebocontrolled, double-blind study. Clin Cosmet Investig Dermatol. 2012;5:159-65. doi: 10.2147/CCID.S36102. Epub 2012 Oct 5.
PubMed 23071399Benzie IF, Strain JJ. The ferric reducing ability of plasma (FRAP) as a measure of "antioxidant power": the FRAP assay. Anal Biochem. 1996 Jul 15;239(1):70-6. doi: 10.1006/abio.1996.0292.
PubMed 8660627Bradford MM. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem. 1976 May 7;72:248-54. doi: 10.1016/0003-2697(76)90527-3. No abstract available.
PubMed 942051Calcabrini C, De Bellis R, Mancini U, Cucchiarini L, Potenza L, De Sanctis R, Patrone V, Scesa C, Dacha M. Rhodiola rosea ability to enrich cellular antioxidant defences of cultured human keratinocytes. Arch Dermatol Res. 2010 Apr;302(3):191-200. doi: 10.1007/s00403-009-0985-z. Epub 2009 Aug 25.
PubMed 19705137Corcuff P, Chatenay F, Leveque JL. A fully automated system to study skin surface patterns. Int J Cosmet Sci. 1984 Aug;6(4):167-76. doi: 10.1111/j.1467-2494.1984.tb00373.x.
PubMed 19467109De Jongh CM, Verberk MM, Withagen CE, Jacobs JJ, Rustemeyer T, Kezic S. Stratum corneum cytokines and skin irritation response to sodium lauryl sulfate. Contact Dermatitis. 2006 Jun;54(6):325-33. doi: 10.1111/j.0105-1873.2006.00848.x.
PubMed 16787454Int J Cosm Sci 6: 167-186, 1984 Fernay, Voltaire The World Medical Association (1989)
Elsner P, Barel AO, Berardesca E, Gapard B, Serup J Skin Bioengineering Techniques and Applications in Dermatology and Cosmetology Karger, 1998
Fuga GC, Spina C, Cavallotti C, Di Palma A, Lombardi G, Marmo W Computerized reflected optical densitometry. A research on the colour of the skin. Journal of Applied Cosmetology, 8:91-110,1990
Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. doi: 10.1111/j.1600-0536.1996.tb02258.x.
PubMed 8896947Garcia Ortiz P, Hansen SH, Shah VP, Menne T, Benfeldt E. Impact of adult atopic dermatitis on topical drug penetration: assessment by cutaneous microdialysis and tape stripping. Acta Derm Venereol. 2009;89(1):33-8. doi: 10.2340/00015555-0562.
PubMed 19197539Grove GL, Zerweck CR, Houser TP, Smith GE, Koski NI. A randomized and controlled comparison of gentleness of 2 medical adhesive tapes in healthy human subjects. J Wound Ostomy Continence Nurs. 2013 Jan-Feb;40(1):51-9. doi: 10.1097/WON.0b013e318276f2a4.
PubMed 23202590ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: May 1996
Lademann J, Meinke MC, Schanzer S, Richter H, Darvin ME, Haag SF, Fluhr JW, Weigmann HJ, Sterry W, Patzelt A. In vivo methods for the analysis of the penetration of topically applied substances in and through the skin barrier. Int J Cosmet Sci. 2012 Dec;34(6):551-9. doi: 10.1111/j.1468-2494.2012.00750.x. Epub 2012 Sep 25.
PubMed 22957937Lademann J, Jacobi U, Surber C, Weigmann HJ, Fluhr JW. The tape stripping procedure--evaluation of some critical parameters. Eur J Pharm Biopharm. 2009 Jun;72(2):317-23. doi: 10.1016/j.ejpb.2008.08.008. Epub 2008 Aug 19.
PubMed 18775778
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations
- ClinicalTrials.gov ID
- NCT02241161
- Acronym / sponsor ID
- E2913
- Conditions
- Healthy
- Keywords
- skin eythema, rejuvenating cream, rejuvenating serum, antioxidant serum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following three cosmetic products and the relative combinations (cream and serum) were assessed: rejuvenating cream, rejuvenating serum, antioxidant serum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| plantaricin a - rejuvenating cream | Active comparator | Other: plantaricin a - rejuvenating creamsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes |
| plantaricin a - rejuvenating serum | Active comparator | Other: plantaricin a - rejuvenating serumsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes |
| plantaricin a - antioxidant serum | Active comparator | Other: plantaricin a - antioxidant serumsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes |
| plantaricin a (rejuvenating cream +rejuvenating serum) | Active comparator | Other: plantaricin a - rejuvenating cream, Other: plantaricin a - rejuvenating serumsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes |
| plantaricin a (rejuvenating cream + antioxidant serum) | Active comparator | Other: plantaricin a - rejuvenating cream, Other: plantaricin a - antioxidant serumsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult volunteers of both sexes, aged more than 18 years old
- Volunteers in a good general state of health in the Investigator opinion
- Volunteers not taking drugs or undergoing surgical procedure
- Volunteers who are giving a written informed consent.
Key exclusion criteria (21 listed)
- Pregnancy (only for female subjects)
- lactation (only for female subjects)
- change in the normal habits in the last month
- participation in a similar study during the previous month
- known allergy to one or several ingredients of the products on trial
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 |
|---|---|---|
| plantaricin a - rejuvenating creamsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other | plantaricin a (rejuvenating cream + antioxidant serum), plantaricin a (rejuvenating cream +rejuvenating serum), plantaricin a - rejuvenating cream |
| plantaricin a - antioxidant serumsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other | plantaricin a (rejuvenating cream + antioxidant serum), plantaricin a - antioxidant serum |
| plantaricin a - rejuvenating serumsingle application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other | plantaricin a (rejuvenating cream +rejuvenating serum), plantaricin a - rejuvenating serum |
Primary outcome
Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0)
Time frame: After 1 (T1h) hour from products application
Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)
8 secondary outcomes
Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0)
Time frame: After 6 (T6h) hours from products application
Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0)
Time frame: After 24 (T24h) hours from products application
Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0)
Time frame: After 1 (T1h) hour from products application
Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0)
Time frame: After 6 (T6h) hours from products application
Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0)
Time frame: After 24 (T24h) hours from products application
Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0)
Time frame: After 1 (Th1) hour from products application
Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0)
Time frame: After 6 (T6h) hours from products application
Surface microrelief evaluation: change from baseline, after 24 hours from products application (T24h) hours from products application vs.T0)
Time frame: After 24 hours (T24h) from products application
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 16 Sep 2014.
- Background: PubMed 23071399Buonocore D, Lazzeretti A, Tocabens P, Nobile V, Cestone E, Santin G, Bottone MG, Marzatico F. Resveratrol-procyanidin blend: nutraceutical and antiaging efficacy evaluated in a placebocontrolled, double-blind study. Clin Cosmet Investig Dermatol. 2012;5:159-65. doi: 10.2147/CCID.S36102. Epub 2012 Oct 5.
- Background: PubMed 8660627Benzie IF, Strain JJ. The ferric reducing ability of plasma (FRAP) as a measure of "antioxidant power": the FRAP assay. Anal Biochem. 1996 Jul 15;239(1):70-6. doi: 10.1006/abio.1996.0292.
- Background: PubMed 942051Bradford MM. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem. 1976 May 7;72:248-54. doi: 10.1016/0003-2697(76)90527-3. No abstract available.
- Background: PubMed 19705137Calcabrini C, De Bellis R, Mancini U, Cucchiarini L, Potenza L, De Sanctis R, Patrone V, Scesa C, Dacha M. Rhodiola rosea ability to enrich cellular antioxidant defences of cultured human keratinocytes. Arch Dermatol Res. 2010 Apr;302(3):191-200. doi: 10.1007/s00403-009-0985-z. Epub 2009 Aug 25.
- Background: PubMed 19467109Corcuff P, Chatenay F, Leveque JL. A fully automated system to study skin surface patterns. Int J Cosmet Sci. 1984 Aug;6(4):167-76. doi: 10.1111/j.1467-2494.1984.tb00373.x.
- Background: PubMed 16787454De Jongh CM, Verberk MM, Withagen CE, Jacobs JJ, Rustemeyer T, Kezic S. Stratum corneum cytokines and skin irritation response to sodium lauryl sulfate. Contact Dermatitis. 2006 Jun;54(6):325-33. doi: 10.1111/j.0105-1873.2006.00848.x.
- BackgroundInt J Cosm Sci 6: 167-186, 1984 Fernay, Voltaire The World Medical Association (1989)
- BackgroundElsner P, Barel AO, Berardesca E, Gapard B, Serup J Skin Bioengineering Techniques and Applications in Dermatology and Cosmetology Karger, 1998
- BackgroundFuga GC, Spina C, Cavallotti C, Di Palma A, Lombardi G, Marmo W Computerized reflected optical densitometry. A research on the colour of the skin. Journal of Applied Cosmetology, 8:91-110,1990
- Background: PubMed 8896947Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. doi: 10.1111/j.1600-0536.1996.tb02258.x.
- Background: PubMed 19197539Garcia Ortiz P, Hansen SH, Shah VP, Menne T, Benfeldt E. Impact of adult atopic dermatitis on topical drug penetration: assessment by cutaneous microdialysis and tape stripping. Acta Derm Venereol. 2009;89(1):33-8. doi: 10.2340/00015555-0562.
- Background: PubMed 23202590Grove GL, Zerweck CR, Houser TP, Smith GE, Koski NI. A randomized and controlled comparison of gentleness of 2 medical adhesive tapes in healthy human subjects. J Wound Ostomy Continence Nurs. 2013 Jan-Feb;40(1):51-9. doi: 10.1097/WON.0b013e318276f2a4.
- Investigation CenterLink provided by the sponsor.
- SponsorLink provided by the sponsor.
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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.
Adele Sparavigna, Doctor principal investigator
Derming SRL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing plantaricin a - rejuvenating cream, plantaricin a - antioxidant serum and plantaricin a - rejuvenating serum in people with Healthy, run by Derming SRL at 1 site in Italy.
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 4 inclusion and 21 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 16 Sep 2014. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0) (time frame: After 1 (T1h) hour from products application). 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 NCT02241161, which also lists 21 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 16 Sep 2014.