Last updated: 11/03/2018 22:55:24
Skin Acceptability Assessment of the cosmetic product SB Translucent, in subjects with all Skin Types Under Normal Usage Conditions.
GSK study ID
204892
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Skin Acceptability Assessment of the cosmetic product SB Translucent, in subjects with all Skin Types Under Normal Usage Conditions.
Trial description: This will be a open label and non-comparative study. The purpose of this clinical trial is to evaluate the acceptability of the cosmetic product in study in research subjects with all skin types by evaluating the absence of adverse events and skin discomfort feelings related to its application, under normal conditions of use, through dermatological follow-up. The subjects will be submitted to dermatological assessment and will use the product at home for 23 (± 2) days. At the end of the study period, the diary will be verified and new dermatological evaluations will be performed on all subjects.
Primary purpose:
Not applicable
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Erythma emergence
Timeframe: Upto 25 days
Edema formation
Timeframe: Upto 25 days
Skin Peeling
Timeframe: Upto 25 days
Intensity of reaction
Timeframe: Upto 25 days
Sensations reported by study subjects
Timeframe: Upto 25 days
Secondary outcomes:
Not applicable
Interventions:
Other: Test Product
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2017-15-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2017 to April 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
18Years - 60Years
Accepts healthy volunteers
Yes
- Signature of the Informed Consent
- Aged between 18 and 60 years old
- Pregnant, Breastfeeding or spouses of pregnant or breast feeding women
- Any skin marks on the test site that might interfere with the evaluation of possible skin reactions
Inclusion and exclusion criteria
Inclusion criteria:
- Signature of the Informed Consent
- Aged between 18 and 60 years old
- Female
- Have any skin type (Dry, oily, normal or combinated)
- Agreement in following the study procedures and attending the clinic on the scheduled days and times.
- Phototype (Fitzpatrick): I to IV
Exclusion criteria:
- Pregnant, Breastfeeding or spouses of pregnant or breast feeding women
- Any skin marks on the test site that might interfere with the evaluation of possible skin reactions
- Active dermatosis (local or disseminated) that might interfere with the study results
- Subjects with immunodeficiency
- Therapeutic, topical or systemic use of the following medications immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 02 weeks before the selection of participants; in case of systemic use of corticosteroids up to 30 days prior to screening
- Hormonal treatments such as contraceptives and not stable hormone replacement therapies in the last three months, regardless of the route of administration
- Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the beginning of the study
- Vaccination up to 03 weeks before the study or during its period
- History of allergic reactions to topical products: cosmetics or drugs
- Currently participating in another clinical trial, or prior participaton in clinical trial terminated within 7 days of screening (21 days if the previous study was a compatibility or adverse reaction investigation study)
- Professionals who are directly involved in the performance of the current protocol as well as their relatives
- Intense sunlight exposure or sun tanning sessions up to 15 days before the baseline evaluation or during the study;
- Aesthetic and/or dermatological treatment performed up to 3 weeks before screening or during the study
- Prisoners or involuntary incarcerated patients;
- Participants from indigenous tribes;
- Any clinical history or condition not mentioned above that in the opinion of the investigator could compromise the study evaluation;
- History of noncompliance or unwillingness to comply with the study protocol
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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