Dermal and Ophthalmological Acceptability Assessment in Sensitive Skin (ADOPS)

Evaluation of the Dermal and Ophthalmological Acceptability of Blancy Pro in Subjects With Sensitive Skin

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.

Study Overview

• Status: Recruiting
• Conditions: Sensitive Skin
• Intervention / Treatment: Other: Blancy Pro

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Santos Arnoni; Phone Number: +55 (11) 94742 3610; Email: beatriz.arnoni@medcin.com.br

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023-070
      • Recruiting
      • Grupo Medcin
      • Contact: Camila Canale; Phone Number: +55 (11) 98343 6952; Email: camila.canale.ext@medcin.com.br
      • Principal Investigator: Sergio Schalka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

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 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.
• Any other condition that, in the investigator's opinion, may justify exclusion from the study. Reasons for exclusion will be documented in the clinical record.
• 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.
• Any other ocular condition that, in the investigator's opinion, may justify exclusion from the study. Reasons for exclusion will be documented in the clinical record.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Product Mostrar mais linhas; 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; Blancy Pro is a cosmetic product evaluated for safety and tolerability in female participants with clinically confirmed sensitive skin through dermatological and ophthalmological assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Investigators: Principal Investigator: Sergio Schalka, Grupo Medcin

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 3, 2026

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26-0161-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan has been established to share individual participant data (IPD) collected during this study. Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No