💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to evaluate the dermatological and ophthalmological safety of a cosmetic product and to assess its comedogenic and acnegenic potential in participants with oily or acne-prone skin. The main questions it aims to answer are:
* Does the investigational product demonstrate an absence of comedogenic potential under normal conditions of use?
* Does the investigational product demonstrate an absence of acnegenic potential under normal conditions of use?
* Does the investigational product demonstrate dermatological and ophthalmological acceptability?
* Does the investigational product present a low risk of irritation or discomfort during the study period?
Participants will:
* Apply the investigational cosmetic product to the face and body twice daily for 28 days.
* Undergo dermatological evaluations to assess skin tolerability and identify any signs of irrit
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Male and female participants aged 18 to 45 years.
* Participants with oily, acne-prone skin.
* Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
* Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
* Normal ophthalmological examination, including slit-lamp evaluation.
Exclusion Criteria:
* Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
* Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
* Skin conditions or marks in the test area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
* History of atopy or allergic reactions to cosmetic products.
* Active skin diseases and/or lesions (localized or widespread) in the assessment area.
* Immunosuppression due to medication use or active disease.
* Uncontrolled endocrine disorders.
* Relevant medical history or current evidence of alcohol or substance abuse.
* Known history of or suspected intolerance to products of the same category.
* 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 reasonably justify exclusion from the study.
Additional Ophthalmological Exclusion Criteria:
* Presence of entropion, ectropion, hordeolum, conjunctivitis, uveitis, or other active ocular diseases at the time of screening.
* Presence of corneal ulceration, blepharitis, meibomian gland dysfunction (meibomitis), pterygium, trichiasis, distichiasis, or other moderate to severe ocular conditions.
* 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 condition that, in the investigator's opinion, may reasonably justify exclusion from the study.
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