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Dermal and Ophthalmological Acceptability Assessment in Sensitive Skin

NCT07771998

RecruitingNA

Sponsor: Brainfarma Industria Química e Farmacêutica S/A

Conditions: Sensitive Skin

Interventions: Blancy Pro

Countries: Brazil

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 overview

Sex: FEMALE

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Osasco, São Paulo, Brazil