Last updated: 11/03/2018 22:56:28

Skin Acceptability Assessment of the cosmetic product SM Translucent, in subjects with sensitive skin Under Normal Usage Conditions

GSK study ID
204907
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Skin Acceptability Assessment of the cosmetic product SM Translucent, in subjects with sensitive skin Under Normal Usage Conditions
Trial description: This will be an open label and non-comparative study. The purpose of this clinical trial is to verify the acceptability of the cosmetic product in study in research subjects with sensitive skin by evaluating the absence of adverse events and feelings of skin discomfort related to its application, under normal conditions of use, through dermatological follow-up. The subjects will will undergo Stinging Test for confirmation of sensitive skin 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:
N\A
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
    Primary completion date:
    2017-22-04
    Observational study model:
    Not applicable
    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
    18 - 60 Year
    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 sensitive skin (checked by positive Stinging Test)
    • 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 subjects; in case of systemic use of corticosteroids up to 30 days prior to screening
    • 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)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    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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