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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
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE March 24, 2017
First Posted Date  ICMJE April 6, 2017
Results First Submitted Date  ICMJE July 10, 2018
Results First Posted Date  ICMJE February 20, 2019
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE May 10, 2017
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
Number of Participants With Evaluator (Dermatologist) Global Assessment (EGA) Score for Well Tolerance of Product 14 Days Post-Procedure [ Time Frame: 14 days after completion of the facial peel procedure ]
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 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 drawn assessment on the total set of clinical and participant self-assessment data for each participant.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • Change From Baseline in Total Score of Dermatologist Assessment Score [ Time Frame: 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 ]
    Participants scored for all domains of Dermatologist Assessment Score using scale of 0 to 3. Erythema (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), Dryness (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 & peeling of skin over all areas of the test site), Desquamation (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 & easily removable), Edema (0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe Marked/pronounced edema present). Total score as 0 to 12, higher scores represent less local tolerance.
  • Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema [ Time Frame: 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 ]
    Participants scored for all domains of Dermatologist Assessment Score using scale of 0 to 3. Erythema (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), Dryness (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 & peeling of skin over all areas of the test site), Desquamation (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 & easily removable), Edema (0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe Marked/pronounced edema present). Higher scores represent less local tolerance.
  • Change From Baseline in Total Score of Participant Self-Assessment Scores [ Time Frame: 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 ]
    Participant Self-Assessment was conducted by participants reflective of their skin condition at the time of evaluation. Participants scored 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). Total score ranges as 0 to 18, higher score represents less tolerance to product applied.
  • Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness [ Time Frame: 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 ]
    Participant Self-Assessment was conducted by participants reflective of their skin condition at the time of evaluation. Participants scored 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). Higher score represents less tolerance to product applied.
  • Change From Baseline in Trans-epidermal Water Loss (TEWL) [ Time Frame: 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 ]
    Trans-epidermal water loss (TEWL) measurement was performed by evaporimetry with a Tewameter to assess skin barrier function. Measurements was done in triplicate on the left cheek (below the cheekbone between the nose and ear). TEWL measurements was performed the participant lying horizontally, on their back, so that the chimney of the Tewameter probe was aligned vertically.
  • Change From Baseline in Corneometer Measurements [ Time Frame: 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 ]
    Corneometry was used to measure moisture content of stratum corneum using corneometer. The corneometer probe was placed in contact with the skin of the participant's test site for 1-2 s per measurement. The corneometer measurements were performed in triplicate at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back. Corneometer values were measured at 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure to evaluate the impact of twice-daily application of the investigational products on skin moisturization compared to the use of no test product. An increase in Corneometer values corresponds to skin-moisturizing effect.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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).
Current Other Pre-specified Outcome Measures
 (submitted: February 19, 2019)
Number of Participants With Global Self-Assessment of Satisfaction Score [ Time Frame: 14 days after completion of the facial peel procedure ]
Participants rated 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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Skin Care
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Cream (Test product)
    • Other: Cleanser (Reference Product)
    • Other: Sunscreen (Reference Product)
  • 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.
    Interventions:
    • Other: Cleanser (Reference Product)
    • Other: Sunscreen (Reference Product)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2018)
106
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
80
Actual Study Completion Date  ICMJE July 19, 2017
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03103906
Other Study ID Numbers  ICMJE 207213
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
PRS Account GlaxoSmithKline
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP