Dermal and Ophthalmological Acceptability Assessment in Sensitive Skin

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.

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.