A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Skin Care

Intervention / Treatment
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* Other: Washout / Standard Cleanser
* Other: Test product
* Other: Positive control cleanser
* Other: Positive control moisturiser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No treatment and Standard cleanser<br>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. | Other: Washout / Standard Cleanser<br>* 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<br>|
| Experimental: Test product and Standard cleanser<br>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. | Other: Washout / Standard Cleanser<br>* 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<br>Other: Test product<br>* 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.<br>|
| Active Comparator: Positive control and positive cleanser<br>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. | Other: Positive control cleanser<br>* 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.<br>Other: Positive control moisturiser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Baseline and Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | At Baseline, Week 1, 4 and 8 |