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

NCT07768800 | Recruiting

• 1 other identifier: 26-0161-04
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oily Skin

Outcome Measures

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.

  Day 28

Secondary Outcomes (1)

• Absence of Comedogenic and Acnegenic Potential

  Baseline (Day 0) to Day 28

Study Arms (1)

Cosmetic Product Group

EXPERIMENTAL

Female participants aged 18 to 60 years with oily and acne-prone skin will use the investigational cosmetic product for 28 days. Dermatological safety, skin tolerability, and the absence of comedogenic and acnegenic potential will be evaluated throughout the study period.

Other: Blancy Pro

Interventions

Blancy Pro OTHER

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.

Cosmetic Product Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Self-identified women who meet all study eligibility criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).

You may not qualify if:

• 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.
• Active skin diseases and/or lesions in the assessment area or elsewhere on the body.
• Immunosuppression due to medication use or active disease.
• Uncontrolled endocrine disorders.
• Relevant medical history or current evidence of alcohol or substance abuse.
• Known history or suspected intolerance to products of the same category as the investigational product.
• Intense sun exposure within 15 days prior to assessment.
• Aesthetic or dermatological treatments within 4 weeks prior to assessment.

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (1)

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

RECRUITING

Study Officials

• Sergio Schalka

  Grupo Medcin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Layane Melody Da Silva Reis Cavalcante

CONTACT

+55 (11) 4507-2183; layane.reis@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are blinded to the identity, brand name, and commercial information of the study product. The product is applied without disclosure of its name or manufacturer to the participants.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: July 20, 2026
• Primary Completion: September 17, 2026
• Study Completion: September 17, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)