Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis

Korábbi kezelés

• Use of systemic immunosuppressive agents, systemic anti-inflammatory medications, or antihistamines within 3 weeks prior to screening.
• Use of topical corticosteroids for the management of atopic dermatitis or psoriasis is permitted and will be documented at enrollment, including active ingredient, concentration, frequency of use, and application site.
• Presence of concomitant dermatological disorders or active skin lesions in the assessment area that could interfere with interpretation of the study results, except for atopic dermatitis or psoriasis.
• Clinically relevant history or current evidence of alcohol or drug abuse.
• Known or suspected intolerance to products of the same category as the investigational product.
• Intense sun exposure within 15 days prior to evaluation.
• Cosmetic or dermatological treatments within 4 weeks prior to evaluation.
• Anticipated need to initiate or modify dermatological drug treatments during the study period.

Más betegség

• Skin conditions in the assessment area that may interfere with the evaluation of cutaneous reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn, except when associated with atopic dermatitis or psoriasis lesions.
• History of allergy to cosmetic products.
• Immunosuppression due to medication use or active disease.
• Uncontrolled endocrine disorders.
• Any other condition that, in the opinion of the investigator, would make participation in the study inappropriate.

Egyéb

• Pregnant or breastfeeding participants, or those at risk of pregnancy, when applicable.

• Male and female participants meeting one of the following age criteria:
• Group I (Atopic Dermatitis): 3 to 12 years or 18 to 50 years of age.
• Group II (Psoriasis): 18 to 65 years of age.
• Group I: Clinical diagnosis of atopic dermatitis with active mild eczema at enrollment and an EASI score between 7.1 and 9 points.
• Group II: Clinical diagnosis of psoriasis with active disease at enrollment, classified as mild to moderate according to PASI, with a score between 1 and 15 points.
• Willingness and ability to comply with study procedures and attend all scheduled visits and assessments.
• Participant, parent, or legally authorized representative able to understand, provide informed consent, and sign the Informed Consent Form (ICF).
• For Group I, participants aged 7 years or older who are able to read and write must understand, provide assent, and sign the Assent Form.