Dermal and Ophthalmological Acceptability Assessment in Sensitive Skin

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorBrainfarma Industria Química e Farmacêutica S/A

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Blancy Pro

    Other intervention

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

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Investigational Product Mostrar mais linhasExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline (D0); D21

Secondary outcomes

Other outcomes

Sponsors and contacts

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