Oily Skin
Conditions
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.
Interventions
OTHERBlancy 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.
Sponsors
Brainfarma Industria Química e Farmacêutica S/A
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatological Safety and Skin Tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Absence of Comedogenic and Acnegenic Potential | 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. |
Countries
Brazil
Contacts
CONTACTLayane Melody Da Silva Reis Cavalcante
PRINCIPAL_INVESTIGATORSergio Schalka
Grupo Medcin
Outcome results
None listed