Dermal and Ophthalmological Acceptability and Comedogenicity Assessment of a Cosmetic Product
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBrainfarma Industria Química e Farmacêutica S/A
About this trial
The goal of this clinical trial is to evaluate the dermatological and ophthalmological safety of a cosmetic product and to assess its comedogenic and acnegenic potential in participants with oily or acne-prone skin. The main questions it aims to answer are:
* Does the investigational product demonstrate an absence of comedogenic potential under normal conditions of use? * Does the investigational product demonstrate an absence of acnegenic potential under normal conditions of use? * Does the investigational product demonstrate dermatological and ophthalmological acceptability? * Does the investigational product present a low risk of irritation or discomfort during the study period?
Participants will:
* Apply the investigational cosmetic product to the face and body twice daily for 28 days. * Undergo dermatological evaluations to assess skin tolerability and identify any signs of irritation or adverse reactions. * Undergo ophthalmological evaluations to assess ocular tolerability. * Undergo clinical assessments to evaluate the comedogenic and acnegenic potential of the investigational product.
The study will enroll 33 male and female participants aged 18 to 45 years with oily or acne-prone skin. Participants will be followed for 28 days while using the investigational product according to the study protocol.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female participants aged 18 to 45 years.
Participants with oily, acne-prone skin.
Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
Disqualifiers
Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
Skin conditions or marks in the test area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
History of atopy or allergic reactions to cosmetic products.
Trial design
Design model
Single group
Treatments tested in this trial
moisturizing cream
Other interventionA cosmetic product applied to the face and body twice daily for 28 days under normal conditions of use. The product will be evaluated for dermal and ophthalmological acceptability, as well as for its comedogenic and acnegenic potential, through clinical dermatological and ophthalmological assessments in participants with oily or acne-prone skin.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Cosmetic Product GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comedogenic and acnegenic potential assessed by clinical dermatological evaluation
Evaluation of the absence of comedogenic and acnegenic potential of the investigational product under normal conditions of use. Clinical dermatological assessments will be performed to identify the occurrence of comedones and acne lesions throughout the study period.
Time frame
Baseline and Day 28Secondary outcomes
1
Dermatological Acceptability Assessed by Dermatologist Clinical Evaluation of Cutaneous Irritation Signs
Dermatological acceptability of the investigational product under normal conditions of use, assessed by a dermatologist through clinical evaluation of cutaneous irritation signs, including erythema, edema, dryness, desquamation, and other skin reactions at Baseline and Day 28.
Time frame
Baseline and Day 282
Ophthalmological acceptability assessed by ophthalmologist clinical evaluation using slit-lamp examination
Participant-reported tolerability of the investigational product assessed through a standardized questionnaire evaluating sensations of burning, stinging, itching, tightness, tearing, ocular discomfort, or other subjective symptoms during the 28-day study period.
Time frame
Day 28Sponsors and contacts
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Source ClinicalTrials.gov