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NCT07848347
Dermal Acceptability Evaluation in Sensitive Skin
Conditions: Sensitive Skin
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 33
Sponsor: Brainfarma Industria Química e Farmacêutica S/A
Location: Grupo Medcin Osasco São Paulo
Summary
The goal of this clinical trial is to evaluate the dermatological safety and acceptability of a cosmetic product in participants with sensitive skin. The main questions it aims to answer are:
* Does the investigational product demonstrate dermatological acceptability in participants with sensitive skin under normal conditions of use?
* Does the investigational product present a low risk of skin irritation?
* What discomfort sensations, if any, are reported by participants with sensitive skin during product use?
Participants will:
* Apply the investigational product to the face and body twice daily under normal conditions of use.
* Undergo clinical dermatological evaluations to assess signs of irritation and product tolerability.
* Report any discomfort sensations experienced during the study period. The study will enroll 33 healthy male and female participants aged 18 years or older with sensitive skin confirmed by a positive Stinging Test. This is a single-center, single-blind clinical trial designed to evaluate the dermatological safety of the investigational product through clinical dermatological assessments under real-world conditions of use.
Eligibility Criteria
Inclusion Criteria:
* Male and female participants aged 18 years or older.
* Participants with sensitive skin, clinically confirmed by a positive Stinging Test.
* Participants with any skin type (combination, oily, dry, or normal skin).
* Intact skin in the assessment area.
* Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for 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, when applicable.
* Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
* Skin conditions or marks in the test area that may interfere with the evaluation of potential skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
* History of atopy or allergic reactions to cosmetic products.
* Active skin diseases and/or lesions (localized or widespread) in the assessment area.
* Immunosuppression due to medication use or active disease.
* Uncontrolled endocrine disorders.
* Relevant medical history or current evidence of alcohol or substance abuse.
* Known history of or suspected intolerance to products of the same category.
* 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 reasonably justify exclusion from the study.
Source: ClinicalTrials.gov (NCT07848347). StuddyBuddy aggregates publicly available trial information.