Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT06997718
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Study Overview
Official Title:
Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, comparative study in parallel groups. In order to perform this clinical study, 60 female/male subjects, aged between 18 and 75 years old, with controlled type 1 or 2 diabetes and presenting foot xerosis and superficial fissures, are enrolled.
The subjects are randomly divided in two groups, (Group I or Group II), where one group applies the test product and another group applies comparative product.
The subjects apply the investigational/comparator products to both feet, twice a day, in the mornings and evenings, for 28 consecutive days.
3 visits are planned :
* Visit 1: Inclusion (D1)
* Visit 2: Intermediate visit (D5 ±2)
* Visit 3: End-of-study visit (D28 ±2)
The subjects are randomly divided in two groups, (Group I or Group II), where one group applies the test product and another group applies comparative product.
The subjects apply the investigational/comparator products to both feet, twice a day, in the mornings and evenings, for 28 consecutive days.
3 visits are planned :
* Visit 1: Inclusion (D1)
* Visit 2: Intermediate visit (D5 ±2)
* Visit 3: End-of-study visit (D28 ±2)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: