Dermal and Ophthalmological Acceptability Assessment in Sensitive Skin

NCT07771998 | Recruiting

• 1 other identifier: 26-0161-03
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-blind clinical study designed to evaluate the safety of the investigational product through dermatological and ophthalmological clinical assessments. A total of 33 female participants, aged 18 to 60 years, with a clinical diagnosis of sensitive skin confirmed by the Stinging Test, will be enrolled. Safety evaluations will be performed throughout the study period using standardized clinical assessments.

Conditions

Sensitive Skin

Outcome Measures

Primary Outcomes (1)

• Dermatological and Ophthalmological Safety Assessment

  Evaluation of the safety of the investigational product under real-world conditions of use by assessing the absence of dermatological and ophthalmological irritation and capturing participant-reported discomfort sensations in individuals with sensitive skin.

  Baseline (D0); D21

Study Arms (1)

Investigational Product Mostrar mais linhas

EXPERIMENTAL

Female participants aged 18 to 60 years with clinically confirmed sensitive skin will receive the investigational product and undergo dermatological and ophthalmological safety assessments throughout the study.

Other: Blancy Pro

Interventions

Blancy Pro OTHER

Blancy Pro is a cosmetic product evaluated for safety and tolerability in female participants with clinically confirmed sensitive skin through dermatological and ophthalmological assessments.

Investigational Product Mostrar mais linhas

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Self-identified women who meet all study eligibility criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18 to 60 years.
• Participants with any skin type, with at least 25% representation of each skin type.
• Participants with sensitive skin, clinically confirmed by the Stinging Test.
• Intact skin in the assessment area.
• Willingness to comply with all study procedures and attend scheduled visits and assessments.
• Ability to understand, 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.
• Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
• Skin marks or conditions 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 disease 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 drug 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.
• Participants with entropion, ectropion, hordeolum (stye), conjunctivitis, uveitis, or other active ocular diseases at screening.
• Participants with corneal ulceration, blepharitis, meibomitis, pterygium, trichiasis, distichiasis, or other moderate to severe ocular disorders.
• Initiation of contact lens use within 1 week prior to screening.
• Use of ophthalmic products, including eye drops and/or ophthalmic ointments, within 3 weeks prior to screening.

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (1)

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

RECRUITING

Study Officials

• Sergio Schalka

  Grupo Medcin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Santos Arnoni

CONTACT

+55 (11) 94742 3610; beatriz.arnoni@medcin.com.br

Study Design

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

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: July 20, 2026
• Primary Completion: September 3, 2026
• Study Completion: September 3, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)