Evaluation of Dermal Acceptability and Comedogenic and Acnegenic Potential of a Cosmetic Product (DACP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oily Skin
• Intervention / Treatment: Other: Blancy Pro

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Santos Arnoni; Phone Number: +55 (11) 94742 3610; Email: beatriz.arnoni@medcin.com.br

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023-070
      • Recruiting
      • Grupo Medcin
      • Contact: Camila Canale; Phone Number: +55 (11) 98343 6952; Email: camila.canale.ext@medcin.com.br
      • Principal Investigator: Sergio Schalka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• Any other condition that, in the investigator's opinion, may interfere with study participation, study evaluations, or justify exclusion from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cosmetic Product Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0) to Day 28

Collaborators and Investigators

• Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Investigators: Principal Investigator: Sergio Schalka, Grupo Medcin

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2026
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): September 17, 2026

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26-0161-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan has been established to share individual participant data (IPD) collected during this study. Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No