Status:
COMPLETED
Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Diabetic Foot Xerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This exploratory study is meant to assess the efficacy of a product in diabetic patients presenting foot xerosis and superficial fissures This exploratory study will be conducted as randomized, compar...
Eligibility Criteria
Inclusion
- Main Inclusion criteria:
- Gender: Male/Female;
- Age: 18 to 75 years old;
- Presenting skin phototype between I and IV according to the Fitzpatrick phototyping scale;
- Presenting controlled type 1 or 2 diabetes;
- Presenting xerosis intensity on feet is rated as 6 according to the Xerosis Assessment Scale (XAS).
- Main Non-inclusion criteria:
- Subject with uncontrolled diabetes and/or with diabetes complications
- Subjects with any foot condition or medical history liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products according to the investigator's assessment
- Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products according to the investigator's assessment
Exclusion
Key Trial Info
Start Date :
February 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06997718
Start Date
February 18 2025
End Date
November 17 2025
Last Update
November 24 2025
Active Locations (1)
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1
Inovapotek
Porto, Portugal, 4200-135