Clinical trial NCT03103906: Evaluation 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 106
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of 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: 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.

Eligibility criteria: 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: a) Fitzpatrick phototype II-IV. b) 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, e) 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)Participants 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, and v) Medical history of Herpes Simplex (Cold Sores).
* a) Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients, b) Documented allergies to cosmetic products or study ingredients.
* a) Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, b) 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.
* a) Required to work outside during daylight hours over the duration of the study, b) 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 Self-Assessed endpoint at any time for the study material sensitivity test.

Primary outcomes:
measure: Number of Participants With Evaluator (Dermatologist) Global Assessment (EGA) Score for Well Tolerance of Product 14 Days Post-Procedure
timeFrame: 14 days after completion of the facial peel procedure
Secondary outcomes:
measure: Change From Baseline in Total Score of Dermatologist Assessment Score
timeFrame: At baseline (60 minutes post procedure but prior to any test product application), 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
measure: Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema
timeFrame: At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
measure: Change From Baseline in Total Score of Participant Self-Assessment Scores
timeFrame: At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
measure: Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness
timeFrame: At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
measure: Change From Baseline in Trans-epidermal Water Loss (TEWL)
timeFrame: At baseline (60 mins. post procedure but prior to any test product application) and 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
measure: Change From Baseline in Corneometer Measurements
timeFrame: At baseline (60 mins. post procedure but prior to any test product application) and 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure
Other outcomes:
measure: Number of Participants With Global Self-Assessment of Satisfaction Score
timeFrame: 14 days after completion of the facial peel procedure
Locations:
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: