💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to evaluate the dermatological safety and efficacy of a moisturizing product in participants with moderate to severe xerosis of the lower limbs. The main questions it aims to answer are:
* Does the investigational product demonstrate dermatological acceptability and absence of irritation under real-world conditions of use?
* Does the investigational product improve skin hydration after single and repeated applications?
* Does the investigational product improve skin barrier recovery and strengthen skin barrier function?
* How do participants perceive the performance and efficacy of the investigational product?
Participants will:
* Apply the investigational moisturizing product twice daily for 28 days.
* Undergo clinical dermatological evaluations to assess skin tolerability and potential irritation.
* Undergo instrumental assessments of skin hydratio
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 36 to 65 years.
* Participants presenting moderate to severe xerosis of the lower limbs, corresponding to grades 2 or 3 on the Overall Dry Skin Score (ODS) scale, confirmed by clinical evaluation.
* Participants presenting a stratum corneum hydration index between 35 and 55 arbitrary units (AU), as measured by corneometry on the forearm during the eligibility assessment.
* Participants considered healthy by the investigator, with no medical conditions or use of medications that could pose an undue risk or interfere with the study results.
* 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).
Exclusion Criteria:
* Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
* Use of anti-inflammatory, immunosuppressive, antihistamine, or any other medication that, in the investigator's opinion, may interfere with skin condition assessments or study outcomes.
* Presence of skin marks in the test area that may interfere with clinical or instrumental evaluations of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
* Presence of active atopic dermatitis, eczema, or other dermatoses that may interfere with evaluation of the test area.
* Active localized or generalized skin diseases and/or lesions in the assessment area that, in the investigator's opinion, may compromise participation in the study.
* Immunosuppression due to medication use or active disease.
* Uncontrolled endocrine disorders.
* Presence of significant vascular alterations in the lower limbs, such as severe venous insufficiency, significant edema, lymphedema, or ulcers that may interfere with study assessments.
* 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 the baseline assessment.
* Aesthetic or dermatological treatments within 4 weeks prior to the baseline assessment.
* Procedures that may temporarily alter skin condition in the test area, such as exfoliation or hair removal, within the timeframe specified by the study protocol.
* Any other condition that, in the investigator's opinion, may pose a risk to the participant, interfere with protocol compliance, or compromise the interpretation of study results.
HealthTeky