Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03103906
Other study ID # 207213
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2017
Est. completion date July 19, 2017

Study information

Verified date February 2019
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date July 19, 2017
Est. primary completion date July 19, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cream (Test product)
Moisturizing cream with SPF (Sun protecting factor) 20
Cleanser (Reference Product)
Moisturizing facial cleanser
Sunscreen (Reference Product)
SPF 50 sunscreen

Locations

Country Name City State
Brazil GSK Investigational Site Campinas São Paulo
Brazil GSK Investigational Site Campinas São Paulo

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Global Self-Assessment of Satisfaction Score 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). 14 days after completion of the facial peel procedure
Primary Number of Participants With Evaluator (Dermatologist) Global Assessment (EGA) Score for Well Tolerance of Product 14 Days Post-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. 14 days after completion of the facial peel procedure
Secondary Change From Baseline in Total Score of Dermatologist Assessment Score 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. 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
Secondary Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema 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. 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
Secondary Change From Baseline in Total Score of Participant Self-Assessment Scores 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. 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
Secondary Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness 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. 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
Secondary Change From Baseline in Trans-epidermal Water Loss (TEWL) 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. 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
Secondary Change From Baseline in Corneometer Measurements 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. 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
See also
  Status Clinical Trial Phase
Completed NCT03302559 - Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage N/A
Completed NCT04510103 - A Controlled Clinical Study of 2 Different Moisturizers for the Relief of Dry Skin N/A
Active, not recruiting NCT04972747 - The Effect of Skin Care Applied With Two Different Oils on Skin Integrity and Growth Parameters in Premature Babies N/A
Completed NCT03640832 - A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin N/A
Completed NCT04557371 - A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations. N/A
Completed NCT03824886 - Enhancing SKIN Health and Safety in Aged CARE N/A
Completed NCT03402373 - Evaluation of the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters N/A
Completed NCT03119688 - To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT) N/A
Recruiting NCT05005611 - Probiotics Regulates Skin Care in Children N/A
Recruiting NCT05337670 - Probiotics Regulates Skin Care in Children N/A
Not yet recruiting NCT05888311 - Evaluation of the Protection of a Liquid Bandage N/A
Not yet recruiting NCT05876546 - Evaluation of Skin Irritancy and Sensitization of a Liquid Bandage N/A
Completed NCT03233009 - To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test N/A
Completed NCT02106403 - A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray N/A
Active, not recruiting NCT03192592 - Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer N/A
Completed NCT03183518 - To Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Participants N/A
Completed NCT03175562 - To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants N/A
Completed NCT05266209 - Comparison of Coconut and Sunflower Oil Application in Preserving Babies' Skin Integrity N/A
Not yet recruiting NCT05738018 - Evaluating Patient Experiences in Skin Care Clinical Studies
Completed NCT02603029 - Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin N/A