Last updated: 08/08/2019 10:10:23
A randomized, evaluator-blind, single-center and two arm clinical study designed to evaluate local tolerance and cosmetic efficacy of 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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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.
Trial description: Evaluation of 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Evaluator (Dermatologist) global assessment of tolerance
Timeframe: 14 days after completion of the facial peel procedure
Secondary outcomes:
Change from baseline in sum of Dermatologist scores for signs/symptoms of erythema, edema, desquamation and dryness
Timeframe: Up to 14 days
Change from baseline in Individual Dermatologist scores for erythema, edema, desquamation and dryness
Timeframe: Up to 14 days
Change from baseline in sum of subject self-assessment scores for redness, pain, stinging/burning, itching, tightness and dryness
Timeframe: Up to 14 days
Change from baseline in Instrumental measurement of barrier function (Tewameter) and moisturisation (Corneometer)
Timeframe: Up to 14 days
Change from baseline in Subject global self-assessment
Timeframe: 14 days after completion of the facial peel procedure
Change from baseline in Individual subject self-assessment scores for redness, pain, stinging/burning, itching, tightness and dryness
Timeframe: Up to 14 days
Interventions:
Enrollment:
113
Primary completion date:
2017-09-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
GI148917, sodium bicarbonate
Collaborators
Not applicable
Study date(s)
February 2017 to May 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
30 - 60 Years
Accepts healthy volunteers
Yes
- 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.
- 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.
- 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.
Inclusion and exclusion 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.
- 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.
- Fitzpatrick phototype II-IV.
- 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.
- Active skin disease or open wound in the test area.
- Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 24 months.
- Medical history of dysplastic nevi or melanoma.
- Preexisting inflammatory dermatoses such as psoriasis, atopic dermatitis.
- Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the investigation.
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to screening (Visit 1) and/or throughout the entire course of the study.
- Systemic use of Over-the-Counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to dosing at the first assessment visit. (Visit 3)
- Systemic use of any photosensitizing medication 2 weeks prior to dosing at the first assessment visit. (Visit 3)
- Intense sun exposure, UV-treatments or tanning salon visit within two weeks prior to dosing at the first assessment visit. (Visit 3)
- One of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer.
- One of the following illnesses if not medicated: Asthma, hypertension.
- Medical history of abnormal response to sunlight.
- Participants with a history of mental illness.
- Ocular surgery within the last 12 months.
- Ocular trauma, infection or inflammation within the last 3 months.
- Blepharitis, conjunctivitis, uveitis.
- Topical ocular treatment within the last 1 month.
- Ocular laser within the last 3 months.
- Aesthetic, cosmetic or dermatological treatment in the treatment area (face), including the use of skin tone lightning products, within the last 1 month.
- Use of facial scrubs, depilatory creams, waxing, bleaching, microdermabrasion, and laser hair removal within the last 1 week prior to screening. (Visit 1)
- 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.
- 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.
- 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.
- 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.
Trial location(s)
Location
GSK Investigational Site
Campinas, São Paulo, Brazil, 13084-791
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2017-09-05
Actual study completion date
2017-09-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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