Dermal Acceptability Evaluation in Sensitive Skin

NCT07848347 | Recruiting

• 1 other identifier: 26-0197-04
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sensitive Skin

Keywords

Sensitive Skin; Dermatological Safety; Dermatological Acceptability; Skin Tolerability; Skin Irritation; Stinging Test; Cosmetic Product; Sensitive Skin Syndrome

Outcome Measures

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.

  Day 21

Study Arms (1)

Investigational Product Group

EXPERIMENTAL

Participants with sensitive skin confirmed by a positive Stinging Test will apply the investigational cosmetic product to the face and body twice daily under normal conditions of use. Dermatological evaluations will be performed to assess product tolerability, irritation, and discomfort sensations throughout the study period.

Other: moisturizing cream

Interventions

moisturizing cream OTHER

A 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.

Also known as: Hydraporin AI Creme

Investigational Product Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (1)

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

RECRUITING

Central Study Contacts

Layane Melody Da Silva Reis Cavalcante

CONTACT

+55 (11) 4507-2183; layane.reis@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 30, 2026
• Study Start: September 8, 2026
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): October 19, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

BR (1)