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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

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ClinicalTrials.gov Identifier: NCT03103906
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Skin Care Other: Cream (Test product) Other: Cleanser (Reference Product) Other: Sunscreen (Reference Product) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : July 19, 2017
Actual Study Completion Date : July 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1 (Test Product)
Participants will apply test product (approximately 0.6-1 grams (g)) to full face topically twice daily (morning and evening) 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: Cream (Test product)
Moisturizing cream with SPF (Sun protecting factor) 20
Other: Cleanser (Reference Product)
Moisturizing facial cleanser
Other: Sunscreen (Reference Product)
SPF 50 sunscreen
Group 2 (No Treatment)
Participants will wet face with water and work a small amount of facial cleanser (approximately 0.6-1 g) into lather. Participants will 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 (Reference Product)
Moisturizing facial cleanser
Other: Sunscreen (Reference Product)
SPF 50 sunscreen



Primary Outcome Measures :
  1. Dermatologist global assessment of tolerance [ Time Frame: 14 days after completion of the facial peel procedure ]
    The Dermatologist will assess 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 below: 0 - Product regimen was well tolerated (No clinically significant worsening of the expected signs/symptoms of the procedure. No new signs/symptoms manifest during product use) and 1 - Product regimen was not well tolerated (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). The Dermatologist will draw on the total set of clinical and participant self-assessment data for each participant.


Secondary Outcome Measures :
  1. Change from baseline in sum of Dermatologist scores for signs/symptoms of erythema, edema, desquamation and dryness [ Time Frame: 14 days after completion of the facial peel procedure ]
    The signs/symptoms of participants will be scored on a scale of 0 to 3. 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.

  2. Change from baseline in Individual Dermatologist scores for erythema, edema, desquamation and dryness [ Time Frame: 14 days after completion of the facial peel procedure ]
    The signs/symptoms of participants will be scored on a scale of 0 to 3. 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.

  3. Change from baseline in sum of participant self-assessment scores for redness, pain, stinging/burning, itching, tightness and dryness [ Time Frame: 14 days after completion of the facial peel procedure ]
    The following assessments will be conducted by participants reflective of their skin condition at the time of evaluation. Participants will score following signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe).

  4. Change from baseline in Individual participant self-assessment scores for redness, pain, stinging/burning, itching, tightness and dryness [ Time Frame: 14 days after completion of the facial peel procedure ]
    The following assessments will be conducted by participants reflective of their skin condition at the time of evaluation. Participants will score following signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe).

  5. Change from baseline in instrumental measurement of barrier function (Tewameter) and moisturisation (Corneometer) [ Time Frame: 14 days after completion of the facial peel procedure ]
    Trans-epidermal water loss (TEWL) measurement will be performed by evaporimetry with a Tewameter. Measurements will be taken in triplicate on the left cheek (below the cheekbone between the nose and ear). TEWL measurements will be taken with the participant lying horizontally, on their back, so that the chimney of the Tewameter probe is aligned vertically. Measurement of stratum corneum hydration will be performed by the electrical capacitance method with a Corneometer. Corneometer measurements will be taken in triplicate at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back.

  6. Change from baseline in participant global self-assessment [ Time Frame: 14 days after completion of the facial peel procedure ]
    Participants will rate the level of satisfaction with the post-procedure skin care regimen to which they were randomized using scale as follows: 0 (Very satisfied), 1 (Satisfied), 2 (Poorly satisfied), 3 (Not at all satisfied).



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103906


Locations
Brazil
GSK Investigational Site
Campinas, São Paulo, Brazil, 13084-791
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03103906     History of Changes
Other Study ID Numbers: 207213
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sunscreening Agents
Glycolic acid
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Keratolytic Agents