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NCT Number: NCT07768800

Evaluation of Dermal Acceptability and 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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

Location status: Recruiting

Location contact

Camila Canale

CONTACT

[email protected]

+55 (11) 98343 6952

Sergio Schalka

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Dermatological Safety and Skin Tolerability

    Time frame: Day 28

    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.

Secondary outcomes

  1. Absence of Comedogenic and Acnegenic Potential

    Time frame: Baseline (Day 0) to Day 28

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz Santos Arnoni

CONTACT

[email protected]

+55 (11) 94742 3610

Sponsors and collaborators

Lead sponsor

Brainfarma Industria Química e Farmacêutica S/A

Industry

Registry information

Official study title

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

Acronym: DACP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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