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Dermal and Ophthalmological Acceptability and Comedogenicity Assessment of a Cosmetic Product

Sponsor: Brainfarma Industria Química e Farmacêutica S/A • ClinicalTrials.gov ID: NCT07848555

Registry updated: 2026-09-30

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Description

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.

Interventions

moisturizing cream (Other)
A 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.

Eligibility criteria

Inclusion Criteria: * 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). * Normal ophthalmological examination, including slit-lamp evaluation. Exclusion Criteria: * 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. * Active skin diseases and/or lesions (localized or widespread) in the assessment area. * Immunosuppression due to medication use or active disease. * Uncontrolled endocrine disorders. * Relevant medical history or current evidence of alcohol or substance abuse. * Known history of or suspected intolerance to products of the same category. * Intense sun exposure within 15 days prior to assessment. * Aesthetic or dermatological treatments within 4 weeks prior to assessment. * Any other condition that, in the investigator's opinion, may reasonably justify exclusion from the study. Additional Ophthalmological Exclusion Criteria: * Presence of entropion, ectropion, hordeolum, conjunctivitis, uveitis, or other active ocular diseases at the time of screening. * Presence of corneal ulceration, blepharitis, meibomian gland dysfunction (meibomitis), pterygium, trichiasis, distichiasis, or other moderate to severe ocular conditions. * Initiation of contact lens use within 1 week prior to screening. * Use of ophthalmic products, including eye drops and/or ophthalmic ointments, within 3 weeks prior to screening. * Any other condition that, in the investigator's opinion, may reasonably justify exclusion from the study.

Conditions

Oily Skin Acne Prone Skin

Locations

Grupo Medcin — Osasco, São Paulo, Brazil

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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