Evaluation of Dermal Acceptability and Comedogenic and Acnegenic Potential of a Cosmetic Product

ConditionOily Skin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBrainfarma Industria Química e Farmacêutica S/A

About this trial

This is a single-center, single-blind clinical study designed to evaluate the dermatological safety of a cosmetic product and to demonstrate the absence of comedogenic and acnegenic potential.

A total of 33 female participants, aged 18 to 60 years, with oily and acne-prone skin will be enrolled. Participants will use the investigational product for 28 days under normal conditions of use.

Dermatological safety, skin tolerability, and the absence of comedogenic and acnegenic effects will be assessed throughout the study period by clinical evaluations conducted according to the study protocol.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female participants aged 18 to 45 years.

Participants with oily and acne-prone skin.

Intact skin in the area intended for application and assessment of the investigational product.

Willingness to comply with all study procedures and attend scheduled visits and assessments.

Disqualifiers

Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.

Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.

Skin conditions or marks in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.

History of atopic conditions or allergy to cosmetic products.

Trial design

Design model

Single group

Treatments tested in this trial

  • Blancy Pro

    Other intervention

    Blancy Pro is a cosmetic product intended for daily use in individuals with oily and acne-prone skin. Participants will use the product for 28 days under normal conditions of use. Dermatological safety and the absence of comedogenic and acnegenic potential will be evaluated through clinical assessments.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Cosmetic Product GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dermatological Safety and Skin Tolerability

Evaluation of the absence of skin irritation risk and assessment of participant-reported discomfort sensations under real-world conditions of use through dermatological clinical evaluations in female participants with oily and acne-prone skin.

Time frame
Day 28

Secondary outcomes

1

Absence of Comedogenic and Acnegenic Potential

Evaluation of the absence of comedogenic and acnegenic potential of the investigational cosmetic product under normal conditions of use in participants with oily and acne-prone skin through dermatological clinical assessments.

Time frame
Baseline (Day 0) to Day 28

Other outcomes

Sponsors and contacts

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