Sensitive Skin
Conditions
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.
Interventions
OTHERBlancy 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.
Sponsors
Brainfarma Industria Química e Farmacêutica S/A
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatological and Ophthalmological Safety Assessment | Baseline (D0); D21 | 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. |
Countries
Brazil
Contacts
CONTACTBeatriz Santos Arnoni
PRINCIPAL_INVESTIGATORSergio Schalka
Grupo Medcin
Outcome results
None listed