Skin CareNCT03093181
A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin
A study testing Washout / Standard Cleanser and Test product in people with Skin Care, run by GlaxoSmithKline at 1 site in Brazil.
Trial summary
This study is designed to evaluate the cosmetic benefit provided by twice daily application of a developmental moisturising cream with niacinamide for 8 weeks in healthy female participants with sensitive, oily, blemish-prone skin. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Washout / Standard Cleanser and Test product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Apr 2017to 28 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- Willingness to actively participate in the study and to attend all scheduled visits
- Minimum of 10 and maximum of 25 blemishes (papules and pustules) at Visit 1 and a minimum of 8 blemishes (papules and pustules) at Visit 2
- Fitzpatrick photo-type I-V
- Sebumeter score of >66 µg / cm2 at the forehead
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant
- Cleanses their face at least once a day
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 12 months
- Change in contraception within the last 3 months
- Active skin disease in the test area
- Medical history of dysplastic nevi or melanoma on the face
Show all 23Show fewer
- Moles, cysts, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the investigation
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to the start of the study and/or throughout the entire course of the study
- Systemic use of anti-microbials within the last month
- Systemic use of over-the-counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to dosing at the first assessment visit
- One of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
- One of the following illnesses if not medicated: Asthma, hypertension
- Medical history of abnormal response to sunlight
- History of mental illness
- Medically diagnosed acne vulgaris, acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic or topical treatment
- No aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month
- No intense sun exposure, Ultraviolet-treatments or tanning salon visit within the last 2 weeks
- Known or suspected intolerance, allergy or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients
- History of allergies to cosmetic products or medicated acne treatments
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last 5 years) of alcohol or other substance abuse
- An employee of the sponsor or the study site or members of their immediate family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-group, Evaluator-blind, No-treatment and Positive Controlled, Single-site, Proof of Concept Clinical Study to Evaluate the Cosmetic Benefit Provided by 8 Weeks of Twice-daily Topical Application of a Developmental Moisturizing Cream With Niacinamide in Healthy Subjects With Sensitive, Oily, Blemish-prone Skin
This study is designed to evaluate the cosmetic benefit provided by twice daily application of a developmental moisturising cream with niacinamide for 8 weeks in healthy female participants with sensitive, oily, blemish-prone skin.
Read the detailed description
This study broadly consists of two phases: screening / washout phase (5-7 day) followed by treatment phase (approximately of 8 weeks). Participants will be asked to return to the study site 1 week, 4 weeks and 8 weeks after their randomisation visit for instrumental measurements and clinical assessments.
- Conditions
- Skin Care
- Being tested
- Washout / Standard Cleanser, Test product, Positive control cleanser, Positive control moisturiser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Washout / Standard CleanserOther
Participants will apply standard cleanser (Simple Kind to Skin Moisturising Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the standard cleanser in a 5-7 day washout period and during the test phase of the study
Test productOther
Participants will apply 0.6 gram (g) of Test product (Moisturising Cream with Niacinamide) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the test product during the test phase of the study.
Positive control cleanserOther
Participants will apply positive control cleanser (Neutrogena Visibly Clear Spot Clearing Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control cleanser during the test phase of the study.
Positive control moisturiserOther
Participants will apply 0.6 g of positive control moisturiser (Vivatinell Acnecinamide Gel Cream) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control moisturiser during the test phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| No treatment and Standard cleanser | Placebo comparator | Participants randomised to the no treatment regimen will use the standard cleanser (only) twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Receives: Other: Washout / Standard Cleanser |
| Test product and Standard cleanser | Experimental | Participants randomised to test product regimen will be instructed to use the standard cleanser and test product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the test product cream immediately after cleansing. Receives: Other: Washout / Standard Cleanser; Other: Test product |
| Positive control and positive cleanser | Active comparator | Participants randomised to positive control regimen will be instructed to use the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the positive control cream immediately after cleansing. Receives: Other: Positive control cleanser; Other: Positive control moisturiser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Corneometer Values at 8 Hours on Day 1
A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization.
Measured: At Baseline and Day 1
Secondary outcomes (6)
Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8
A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturisation. Measurement of skin moisturisation was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. Higher Corneometer values are indicative of improved skin moisturisation.
Measured: At Baseline, Day 1, Week 1, 4 and 8
Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline
The baseline and week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting and all practical efforts were made to minimize glare. The relative positioning (left and right) of baseline and week 8 photographs were blinded to evaluator and randomized. A technician used randomization schedule to display pair of images to lay evaluator. Lay evaluators judged magnitude of improvement in overall appearance of blemishes using the below criteria: Left=blemishes on left are more obvious than those on the right and Right=blemishes on right are more obvious than those on the left. Layperson ranked both left and right image as follows:1=Better;2=Worse. Odds was calculated from logistic regression including treatment and age stratum effects and exchangeable correlation. Odds=p/(1-p) where p was the probability of event that Week 8 was better than baseline.
Measured: At Baseline and Week 8
ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline
Baseline and Week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting with minimized glare. Relative positioning (left and right) of baseline and Week 8 photographs were blinded to evaluator and randomized. Lay evaluators ranked magnitude of improvement in overall appearance of blemishes using below criteria: Left=blemishes on left are more obvious than those on right; Right=blemishes on right are more obvious than those on left. Lay evaluator ranking for each image pair was converted into a numerical score based on whether Baseline or Week 8 image was ranked better:0=Baseline image was better than Week 8 image,1=Week 8 image was better than Baseline image. Minimum score 0 corresponded to all baseline images being better than Week 8 images. Maximum score 1 corresponded to all Week 8 images being better than baseline images. Higher scores indicated better results.
Measured: At Baseline and Week 8
Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8
A treatment blind, trained and qualified evaluator counted the total number of facial blemishes on the forehead, cheeks and chin of the participants.
Measured: At Baseline, Week 1, 4 and 8
Change From Baseline in Sebumeter Values at Week 1, 4 and 8
A treatment blinded, trained and qualified evaluator conducted instrumental measurements of skin sebum levels. Measurement of skin sebum levels was performed by with a Sebumeter SM 815. The measurement principle of the SM 815 is based on grease spot photometry. The translucent tape of the device is brought into contact with skin and becomes increasingly transparent in response to surface oil. The tape is inserted into the aperture of the device and its transparency measured by light transmission, with increased transmission signifying increased oiliness. The software outputs mass sebum levels as a function of area. Sebumeter measurements were taken in triplicate at the central forehead (above the eyebrows) with the participant lying horizontally, on their back.
Measured: At Baseline, Week 1, 4 and 8
Change From Baseline in Sebum Excretion Rate at Week 1, 4 and 8
The forehead of each participant was thoroughly cleansed by the investigator or designee using cotton pads saturated with 70% Isopropyl Alcohol and, after 5 minutes, the central area of the forehead above the eyebrows was measured in triplicate with a Sebumeter. The same area was measured in triplicate 90 minutes after cleansing. The sebum excretion rate was calculated by the difference in 90th minutes and 5th minute Sebumeter values.
Measured: At Baseline, Week 1, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start4 Apr 2017
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093181
- Sponsor's protocol ID
- 207196
- Status last verified
- Feb 2020
- First submitted
- 24 Mar 2017
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santos-Caetano JP, Gfeller CF, Mahalingam H, Thompson M, Moore DJ, Vila R, Doi R, Cargill MR. Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomized proof-of-concept study. Int J Cosmet Sci. 2020 Feb;42(1):29-35. doi: 10.1111/ics.12576. Epub 2020 Jan 6.
PubMed 31461548
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group, Evaluator-blind, No-treatment and Positive Controlled, Single-site, Proof of Concept Clinical Study to Evaluate the Cosmetic Benefit Provided by 8 Weeks of Twice-daily Topical Application of a Developmental Moisturizing Cream With Niacinamide in Healthy Subjects With Sensitive, Oily, Blemish-prone Skin
- ClinicalTrials.gov ID
- NCT03093181
- Acronym / sponsor ID
- 207196
- Conditions
- Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the cosmetic benefit provided by twice daily application of a developmental moisturising cream with niacinamide for 8 weeks in healthy female participants with sensitive, oily, blemish-prone skin.
Detailed description
This study broadly consists of two phases: screening / washout phase (5-7 day) followed by treatment phase (approximately of 8 weeks). Participants will be asked to return to the study site 1 week, 4 weeks and 8 weeks after their randomisation visit for instrumental measurements and clinical assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment and Standard cleanser | Placebo comparator | Other: Washout / Standard CleanserParticipants randomised to the no treatment regimen will use the standard cleanser (only) twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. |
| Test product and Standard cleanser | Experimental | Other: Washout / Standard Cleanser, Other: Test productParticipants randomised to test product regimen will be instructed to use the standard cleanser and test product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the test product cream immediately after cleansing. |
| Positive control and positive cleanser | Active comparator | Other: Positive control cleanser, Other: Positive control moisturiserParticipants randomised to positive control regimen will be instructed to use the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the positive control cream immediately after cleansing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- Willingness to actively participate in the study and to attend all scheduled visits
- Minimum of 10 and maximum of 25 blemishes (papules and pustules) at Visit 1 and a minimum of 8 blemishes (papules and pustules) at Visit 2
- Fitzpatrick photo-type I-V
Key exclusion criteria (23 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 12 months
- Change in contraception within the last 3 months
- Active skin disease in the test area
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 |
|---|---|---|
| Washout / Standard CleanserParticipants will apply standard cleanser (Simple Kind to Skin Moisturising Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the standard cleanser in a 5-7 day washout period and during the test phase of the study | Other | No treatment and Standard cleanser, Test product and Standard cleanser |
| Test productParticipants will apply 0.6 gram (g) of Test product (Moisturising Cream with Niacinamide) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the test product during the test phase of the study. | Other | Test product and Standard cleanser |
| Positive control cleanserParticipants will apply positive control cleanser (Neutrogena Visibly Clear Spot Clearing Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control cleanser during the test phase of the study. | Other | Positive control and positive cleanser |
| Positive control moisturiserParticipants will apply 0.6 g of positive control moisturiser (Vivatinell Acnecinamide Gel Cream) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control moisturiser during the test phase of the study. | Other | Positive control and positive cleanser |
Primary outcome
Change From Baseline in Corneometer Values at 8 Hours on Day 1
Time frame: At Baseline and Day 1
A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization.
6 secondary outcomes
Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8
Time frame: At Baseline, Day 1, Week 1, 4 and 8
Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline
Time frame: At Baseline and Week 8
ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline
Time frame: At Baseline and Week 8
Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8
Time frame: At Baseline, Week 1, 4 and 8
Change From Baseline in Sebumeter Values at Week 1, 4 and 8
Time frame: At Baseline, Week 1, 4 and 8
Change From Baseline in Sebum Excretion Rate at Week 1, 4 and 8
Time frame: At Baseline, Week 1, 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31461548Santos-Caetano JP, Gfeller CF, Mahalingam H, Thompson M, Moore DJ, Vila R, Doi R, Cargill MR. Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomized proof-of-concept study. Int J Cosmet Sci. 2020 Feb;42(1):29-35. doi: 10.1111/ics.12576. Epub 2020 Jan 6.
- Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomised proof-of-concept study.Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Washout / Standard Cleanser and Test product in people with Skin Care, run by GlaxoSmithKline at 1 site in Brazil.
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 8 inclusion and 23 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 24 Feb 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Corneometer Values at 8 Hours on Day 1 (time frame: At Baseline and Day 1). 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 NCT03093181, which also lists 1 linked publication.
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 24 Feb 2020.