Last updated: 11/03/2018 22:57:22

Comedogenic and acnegenic potential evaluation with ophthalmologic evaluation of the cosmetic product SM Medium Beige - in-use study.

GSK study ID
204922
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: Comedogenic and acnegenic potential evaluation with ophthalmologic evaluation of the cosmetic product SM Medium Beige - in-use study.
Trial description: This will be an open-label and non-comparative study to prove the absence of comedogenic and acnegenic potential of the investigational product in normal conditions of use and to evaluate the product safety from the general and ophthalmological point of view. Subjective ophthalmological and dermatological clinical evaluation and count of comedones, papules and pustules will be performed before and after 28 days of product use.
Primary purpose:
Not applicable
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Comedogenic or acnegenic potential assessment

Timeframe: Up to 30 days

Dermatological and ophthalmological assessment

Timeframe: Up to 30 days

Subjective assessment

Timeframe: Up to 30 days

Secondary outcomes:
Not applicable
Interventions:
  • Other: Test product
    • Enrollment:
    0
    Primary completion date:
    2017-13-06
    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)
    April 2017 to June 2017
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18Years - 45Years
    Accepts healthy volunteers
    Yes
    • Signature of the Informed Consent
    • Aged between 18 and 45 years old
    • Pregnant, Breastfeeding or spouses of pregnant or breast feeding women
    • Start/end of contraceptive use 3 months before selection (if female)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Signature of the Informed Consent
    • Aged between 18 and 45 years old
    • Both gender (male or female)
    • Oily skin tending to comedones and acne lesions
    • Intact skin in the product analysis region
    • Normal ophthalmologic examination
    • Participants being user of cosmetic products of the same category
    • Agreement to comply with test procedures and to attend the clinic at days and times determined for evaluations and counting of comedone
    • Phototype (Fitzpatrick): I to IV
    Exclusion criteria:
    • Pregnant, Breastfeeding or spouses of pregnant or breast feeding women
    • Start/end of contraceptive use 3 months before selection (if female)
    • Use of anti-inflammatory/immunosuppressive/antihistaminic drugs and/or new drugs for up to 15 days before screening
    • Active (local and/or disseminated) skin diseases in the evaluation area
    • Hormonal diseases that can trigger acne/acne lesions
    • Diseases that cause immune suppression, such as diabetes, human immunodeficiency virus (HIV), etc
    • Endocrine diseases such as thyroid diseases, ovarian or adrenal gland disorders
    • Use of contact lens up to 1 week before screening
    • Use of ophthalmic products (eye drops and/or ophthalmic ointments) up to 1 week before screening
    • Vaccination up to 3 weeks before the study or during its conduction
    • Atopic or allergic history to cosmetic products
    • Known history or suspected intolerance to any ingredient of the products in study (test products or comparators)
    • Previous participation in a study with the same product in test
    • Participation in other studies in less than 7 days. If the previous test is any Compatibility test [as defined in the Guidance for Safety Evaluation of Cosmetic Products
    • Agência Nacional de Vigilância Sanitária (ANVISA)
    • 2012], the interval should be equal or superior to 21 days
    • Participation in other study (of medicines, cosmetics or any other product) concomitant to this test
    • Use of specific cosmetic for skin with oily/acne such as makeup, facial moisturizers, etc. up to 7 days before screening
    • Intense sun exposure or tanning session up to 15 days before initial evaluation or during the study
    • Esthetical treatments, dermatological treatments up to 4 weeks before screening
    • Other conditions considered by the investigator as reasonable for disqualification from study participation
    • Relevant clinical history or current evidence of alcohol or other drugs abuse
    • Prisoners or involuntarily incarcerated patients
    • Participants from Indian tribes
    • Employees of the contract research organization (CRO) or the sponsoring company involved in the study, or close family member of an employee involved in the study

    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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