Assessment of the Cosmetic Benefit of a Skin Cream in Healthy Females With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a Glycolic Acid Facial Peel Procedure

Study Overview
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Brief Summary
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To evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in healthy female participants with mild to advanced photo-damaged facial skin who have undergone a 70% Glycolic Acid facial peel procedure.

Detailed Description
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This will be a randomized, evaluator-blind, single-center and two-arm clinical study designed to evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in healthy female participants with mild to advanced photo-damaged facial skin who have undergone a 70% Glycolic Acid facial peel procedure.

Official Title
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A Randomized, Evaluator-blind, Single-center and Two-arm Clinical Study Designed to Evaluate the Local Tolerance and Cosmetic Efficacy of a Topical Skin Care Formulation in Healthy Female Subjects With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a 70% Glycolic Acid Facial Peel Procedure

Conditions
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Skin Care

Intervention / Treatment
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* Other: Test Product
* Other: Cleanser
* Other: Sunscreen


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. Females aged between 30 and 60 years inclusive. 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. Skin Type: Fitzpatrick phototype II-IV and participants with Glogau photoaging type II-III Females of childbearing potential who are, in the opinion of the investigator, practising 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. 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. a) Active skin disease or open wound in the test area, b) Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 24 months, c)Medical history of dysplastic nevi or melanoma, d) Preexisting inflammatory dermatoses such as psoriasis, atopic dermatitis, e) Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could, in the opinion of the investigator, influence the investigation, f) Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to screening and/or throughout the entire course of the study, g) Systemic use of over-the-counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to screening. h)Systemic use of any photosensitizing medication 2 weeks prior to screening, i) Intense sun exposure, UV-treatments or tanning salon visit within two weeks prior to screening, j) One of the following illnesses that might require regular systemic medication; Insulin-dependent diabetes, cancer, k) One of the following illnesses if not medicated: Asthma, hypertension, l) Medical history of abnormal response to sunlight, m) Participant's with a history of mental illness, n) Ocular surgery within the last 12 months. o) Ocular trauma, infection or inflammation within the last 3 months, p) Active blepharitis, conjunctivitis, uveitis, q) Any ocular pathology requiring topical ocular treatment within the last 1 month, r) Ocular laser within the last 3 months, s) Aesthetic, cosmetic or dermatological treatment in the treatment area (face), including the use of skin tone lightning products, within the last 3 months, t) Use of facial scrubs, depilatory creams, waxing and/or bleaching within the last 2 weeks prior to screening, u) Microdermabrasion and/or laser hair removal within the last 4 weeks prior to screening, v) Medical history of Herpes Simplex (Cold Sores). Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients and documented allergies to cosmetic products or study ingredients. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit and 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. Required to work outside during daylight hours over the duration of the study and required or otherwise intending to spend prolonged periods of time outside during daylight hours over the duration of the study (e.g. holiday, sunbathing, and gardening). A score of Severe for any Dermatologist or Participant's Self-Assessed endpoint at any time for the study material sensitivity test.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Group 1<br>Participants will apply a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips and will apply twice daily (morning and evening) to the full face after cleansing. All participants will be instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime. | Other: Test Product<br>* Restoring lipid balm<br>Other: Cleanser<br>* Moisturizing facial cleanser<br>Other: Sunscreen<br>* SPF (Sun Protection Factor) 50 sunscreen<br>|
| Other: Group 2<br>Participants will wet face with water and work a small amount of facial cleanser (approximately 0.6-1 g) into lather. Massage topically onto wet skin and rinse with water twice daily (morning and evening). After cleansing, participants will apply a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime. | Other: Cleanser<br>* Moisturizing facial cleanser<br>Other: Sunscreen<br>* SPF (Sun Protection Factor) 50 sunscreen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores | The dermatologist assessed the local tolerance of the post-procedure skin care regimen in context of the expected effects of the procedure for each participant using the scale as below: 0 - Product regimen was well tolerated, 1 - product regimen was not well tolerated. The dermatologist observed on the total set of clinical and participant self-assessment data for each participant. Lower scale value implies that no clinically significant worsening of the expected signs/symptoms of the procedure, no new signs/symptoms manifest during product use. Whereas, higher scale value implies clear, clinically relevant worsening of the severity or frequency of expected signs/symptoms of the procedure and/or any occurrence of new, unexpected signs/symptoms during product use. | 14 days after completion of the facial peel procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Score of Dermatologist Assessments | The assessments of Erythema, Dryness, Desquamation and Edema were conducted by a dermatologist on the participant's skin condition at the 5 x 5 cm square area on the volar surface of forearm. The signs were scored on a scale. Erythema on 0-3 where, 0=none-no redness, 1=mild-slight redness, 2=moderate-definite redness, 3=severe-marked redness. Dryness on 0-3 where, 0=none-no dryness, 1=mild-barely perceptible, fine scales to limited areas of test site, 2=moderate-fine scales generalized to all areas of test site, 3=severe-scaling and peeling of skin over all areas of test site. Desquamation on 0-3 where, 0=none-no sign of peeling, 1=mild-barely perceptible scaling, 2=moderate-minimal scaling, 3=severe-moderate scaling. Edema on 0-3 where, 0=none-no edema, 1=mild-barely perceptible edema, 2=moderate-definite edema, 3=severe-pronounced edema. The measure is sum of participant scores, so a total score scale ranges from 0-12, with higher scores indicating increased signs of irritation. | 14 days after completion of the facial peel procedure | 
| Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness | The signs/symptoms of participants were scored on a scale of 0 to 3 as below: Erythema: Score from 0=None-No evidence of erythema present, 1=Mild-Slight red coloration, 2=Moderate-Definite redness, 3=Severe-Marked erythema, bright red to dusky dark red in color. Dryness: Score from 0=None-No dryness, 1=Mild-Barely perceptible, fine scales or flakes present to limited areas of the test site, 2=Moderate-Fine scales or flakes generalized to all areas of the test site, 3=Severe -Scaling and peeling of skin over all areas of the test site. Desquamation score from 0=None-No evidence of desquamation/peeling, 1=Mild-Barely perceptible scaling; evident only on scratching, 2=Moderate-Minimal scaling, adherent to the skin, 3=Severe -Moderate scaling, loosely adherent to the skin and easily removable. Edema score from 0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe-Marked/pronounced edema present. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Sum of Participant Self-assessment Scores for Redness, Pain, Stinging/Burning, Itching, Tightness and Dryness | The assessments of Pain, Stinging/ Burning, Itching, Tightness, Redness and Dryness were conducted by participants reflective of their skin condition at the 5 x 5 cm square area on the volar surface of the forearm at the time of evaluation. Participants were scored as per signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3, where 0= none; no sign or symptoms, 1= mild; barely perceptible, 2= moderate; definite signs and symptoms, and 3= severe- marked or pronounced signs or symptoms. This outcome measure is the sum of participant scores, so a total score, i.e. the range is 0-15, with higher scores indicating increased signs or symptoms of irritation. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Participant Self-assessment Scores for Redness | The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for redness. Participants were score on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Participant Self-assessment Scores for Pain | The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for pain. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Participant Self-assessment Scores for Itching | The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for itching. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Participant Self-assessment Scores for Stinging/Burning | The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for stinging/burning. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Participant Self-assessment Scores for Tightness | The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for tightness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Participant Self-assessment Scores for Dryness | The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for dryness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Instrumental Measurement of Barrier Function Using Tewameter | Trans-epidermal water loss (TEWL) measurement was performed by evaporimetry with a Tewameter. Measurements were taken in triplicates on the left cheek (below the cheekbone between the nose and ear). TEWL measurements were taken with the participant lying horizontally, on their back, so that the chimney of the Tewameter probe is aligned vertically. An increase in TEWL values shows damage to the skin barrier function. | 14 days after completion of the facial peel procedure | 
| Change From Baseline in Instrumental Measurement of Moisturisation Using Corneometer | Measurement of stratum corneum hydration was performed by the electrical capacitance method with a Corneometer. Corneometer measurements were taken in triplicates at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa. | 14 days after completion of the facial peel procedure | 
| Global Self-assessment of Participants | Participants has rated the level of satisfaction with the post-procedure skin care regimen to which they were randomized on a scale of 0 to 3 as follows: 0 (Very satisfied), 1 (Satisfied), 2 (Poorly satisfied), 3 (Not at all satisfied). Lower scores indicate better results. | 14 days after completion of the facial peel procedure |