Last updated: 11/03/2018 23:20:24
A comparative, open-label, randomized, and controlled clinical efficacy trial for preview evaluation of the skin oiliness control for three cosmetics products
GSK study ID
205434
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: A comparative, open-label, randomized, and controlled clinical efficacy trial for preview evaluation of the skin oiliness control for three cosmetics products
Trial description: The objective of this study is to evaluate the clinical efficacy of three cosmetics to control skin oiliness through the measurement of the sebum amount in the skin (using sebumetry assessment). The measurements will be performed before product application and after 8 and 12 hours of the product application.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Skin oil assessment
Timeframe: Baseline and upto 12 hours
Secondary outcomes:
Not applicable
Interventions:
Other: Test product-Phototype-2
Other: Test product-Prototype-3
Other: Test product-Prototype-1
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2016-08-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2016 to September 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18Years - 40Years
Accepts healthy volunteers
Yes
- Participants who have signed the consent form
- Healthy research participants;with Intact skin on the test region (face), male and female of age group 18-40 years old
- Pregnant and breastfeeding women, or their partners
- Skin pathology in the area of product application (face)
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who have signed the consent form
- Healthy research participants;with Intact skin on the test region (face), male and female of age group 18-40 years old
- Agreement to comply with trial procedures and requirements, and to visit the institute on the day(s) and time(s) scheduled for the evaluations
- Ability to consent with participation in writing
- Fitzpatrick (Phototype I to V)
- Oily skin on the face (sebumetry values (forehead) should be at least 100 in each halfface- 3 measures for half-face)
- Not have used cosmetic products (including regular soap) 12h before evaluation in face
Exclusion criteria:
- Pregnant and breastfeeding women, or their partners
- Skin pathology in the area of product application (face)
- Type 1 Diabetes Mellitus, gestational or with complications (retinopathy, nephropathy, neuropathy) and/or insulin users and/or presence of dermatosis related to diabetes mellitus (plantar ulcer, necrobiosis lipoidica, granuloma annulare, dermatophytosis, deep mycosis, bacterial infections, opportunistic infections) and/or history of hypoglycemic episodes, diabetic ketoacidosis and/or hyperosmolar coma
- Immune failure, Use of systemic corticosteroids or immunosuppressants within 2 weeks prior to study start
- Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis or any other dermatosis which may interfere with the study results
- Other diseases or medications which may interfere directly with the study or jeopardize the volunteer’s health
- History of reaction to the category of the tested product,History of allergies or sensitivity to cosmetics, toiletries, sunscreen and / or topical products and known allergy to latex
- Participation in other studies within the last 7 days. In case the previous test is any Compatibility test (as defined in the Guide of Safety Evaluation of Cosmetics – ANVISA – 2012), the interval must be equal to or higher than 21 days
- Relevant clinical history or current evidence of abuse of alcohol or other drugs
- Prisoners or patients involuntarily incarcerated or Volunteers from indigenous tribes
- People working for Allergisa or the sponsoring company involved in the study or close relatives of an employee involved in the study
- Vaccination within 3 weeks before or during the study
- Participation in other studies (drugs, cosmetics or any other product) simultaneously to this test
- Participation in previous study with same product under test
- Presence of sunburn, tanning, uneven skin tone, spots, nevus, seborrheic keratosis or excessive hair on the area of the test
- Any condition not previously mentioned that may impair the study evaluation and/or safety of the participant in the investigator’s opinion -
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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