Dermal Acceptability Evaluation in Sensitive Skin
ConditionSensitive Skin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrainfarma Industria Química e Farmacêutica S/A
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
moisturizing cream
Other interventionA cosmetic product applied to the face and body twice daily under normal conditions of use. The product will be evaluated for dermatological acceptability and tolerability in participants with sensitive skin confirmed by a positive Stinging Test. Clinical dermatological assessments will be performed throughout the study period to evaluate signs of irritation and participant-reported discomfort sensations.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Investigational Product GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Severity of Dermatological Signs and Symptoms Assessed by Clinical Dermatological Evaluation
Dermatological evaluation of the occurrence and severity of erythema, edema, desquamation, pruritus, burning sensation, vesicles, papules, irritation, or other clinical signs and symptoms of adverse events. Severity was assessed using a 4-point scale ranging from 0 to 3, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Higher scores indicate greater severity of dermatological signs and symptoms and therefore a worse outcome.
Time frame
Day 21Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov