Moisturizing Cream for moderate to severe xerosis of the lower legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates a moisturizing cream in adults aged 36–65 with moderate to severe xerosis of the lower limbs. Participants apply the product twice daily for 28 days and undergo dermatological checks for tolerability and irritation. Instrumental measures of skin hydration (Corneometer) and skin barrier function (Tewameter) are used, along with participant questionnaires about perceived performance. The study seeks to determine dermatological acceptability, hydration improvement after single and repeated applications, barrier recovery, and overall user perception under real-world use conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Grupo Medcin
  Osasco, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Sergio Schalka — Grupo Medcin
• Study coordinator: Layane Melody Da Silva Reis Cavalcante
• Email: layane.reis@brainfarma.ind.br
• Phone: +55 (11) 4507-2183

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.