Evaluating a product for diabetic foot dryness and cracks
Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
This study is testing a new product to see if it can help people with diabetes who have dry and cracked feet feel better over 28 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pierre Fabre Dermo Cosmetique Industry-sponsored |
| Locations | 1 site (Porto) |
| Trial ID | NCT06997718 on ClinicalTrials.gov |
What this trial studies
This exploratory study assesses the efficacy of the product RV5075A-MF6793 in diabetic patients suffering from foot xerosis and superficial fissures. It involves a randomized, comparative design with 60 participants aged 18 to 75 years, who have controlled type 1 or 2 diabetes. Participants will be divided into two groups, with one applying the investigational product and the other using a comparative product, both applied twice daily for 28 days. The study includes three visits to monitor progress and outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 75 with controlled type 1 or 2 diabetes and significant foot xerosis.
Not a fit: Patients with uncontrolled diabetes or other foot conditions that could interfere with the study outcomes may not benefit.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for diabetic patients suffering from foot dryness and fissures.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in treating skin conditions in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Porto
- Inovapotek — Porto, Portugal (Recruiting)
Study contacts
- Study coordinator: Adeline Bacquey
- Email: adeline.bacquey@pierre-fabre.com
- Phone: +33534506533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.