Diabetic Foot XerosisNCT06997718
Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
A study testing RV5075A MF6793 and CO5075A in people with Diabetic Foot Xerosis, run by Pierre Fabre Dermo Cosmetique at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Xerosis
- What is being tested?
- RV5075A MF6793 and CO5075A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Feb 2025to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
- Conditions
- Diabetic Foot Xerosis
- Being tested
- RV5075A MF6793, CO5075A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV5075A MF6793Other
Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.
CO5075AOther
Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: RV5075A MF6793 |
| Comparative group | Active comparator | Not described Receives: Other: CO5075A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)
Evaluation performed by the investigator, giving 1 XAS score for both feet/patient (9 points scale, from 0 = Normal skin, to 8 =Skin with deep fissures).
Measured: Before (Day 1 Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Evolution of superficial fissures intensity on both feet with VAS (Visual Analog Scale)
Evaluation performed by the investigator, giving 1 VAS score for both feet/patient (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Measured: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Evolution of superficial fissures intensity on a target fissure with VAS (Visual Analog Scale)
Evaluation performed by the investigator specifically on the target fissure identified at the inclusion visit, on VAS (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Measured: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Quality of Life evaluation by the patient
Filling by the patient of a 13-questions questionnaire about their quality of life related to their feet condition.
Measured: Before (Day 1, Visit 1), and after 28 (Visit 3) consecutive days of products' application
Global soothing effect evaluation on feet
The global soothing is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no relief/no soothing effect to 100 mm = complete relief/total soothing effect)
Measured: After the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of pruritus/itchiness on feet
The evolution of pruritus intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no itching or pruritus at all, to 100 mm = extreme itching, unbearable)
Measured: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of tingling on feet
The evolution of tingling intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tingling sensation, to 100 mm = intense tingling, very uncomfortable)
Measured: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of tightness on feet
The evolution of tightness intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tightness at all, to 100 mm = extreme tightness, uncomfortable)
Measured: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of pain on feet
The evolution of pain intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no pain at all, to 100 mm = extreme pain, debilitating)
Measured: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Skin hydration
Skin capacitance is assessed instrumentally by an expert, on the selected foot of each subject
Measured: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Standardized photographs of the target fissure of each subject to visually assess the evolution of the target fissure.
Measured: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Cosmetic satisfaction and perceived effect evaluation questionnaire
Filling by the patient of a subjective evaluation questionnaire considering their cosmetic acceptability, and perceived efficacy towards the investigational/comparator product
Measured: After the first application (Day 1, Visit 1), and after 5 (Visit 2), 15 (at home) and 28 (Visit 3) consecutive days of products' application
Standardized photograph of the selected foot of each subject is taken for illustrative purposes
Measured: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Compliance of the subject to the product
Subjects fill in a subject diary (daily log) during the course of the study to record their compliance to the product.
Measured: During the entire course of the study, from inclusion visit (Day 1), to the end-of-study visit (Day 28).
Global assessment of the tolerance
Global assessment of the tolerance is assessed by the investigator for each subject at the end of the study considering all individual adverse events and their characteristics, based on a 5-point scale (from excellent tolerance to bad tolerance).
Measured: At the end of the study (after 28 consecutive days of products' twice-daily application), or premature withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start18 Feb 2025
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot XerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects are randomly divided in two groups, according to the randomization list, where one group applies the test product (product code: RV5075A), and another group applies comparative product (product code: CO5075A).
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997718
- Sponsor's protocol ID
- RV5075A20240673
- Status last verified
- Nov 2025
- First submitted
- 14 May 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
- ClinicalTrials.gov ID
- NCT06997718
- Acronym / sponsor ID
- RV5075A20240673
- Conditions
- Diabetic Foot Xerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subjects are randomly divided in two groups, according to the randomization list, where one group applies the test product (product code: RV5075A), and another group applies comparative product (product code: CO5075A).
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: RV5075A MF6793 |
| Comparative group | Active comparator | Other: CO5075A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV5075A MF6793Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount. | Other | Test group |
| CO5075ATwice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount. | Other | Comparative group |
Primary outcome
Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)
Time frame: Before (Day 1 Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Evaluation performed by the investigator, giving 1 XAS score for both feet/patient (9 points scale, from 0 = Normal skin, to 8 =Skin with deep fissures).
Evolution of superficial fissures intensity on both feet with VAS (Visual Analog Scale)
Time frame: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Evaluation performed by the investigator, giving 1 VAS score for both feet/patient (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Evolution of superficial fissures intensity on a target fissure with VAS (Visual Analog Scale)
Time frame: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Evaluation performed by the investigator specifically on the target fissure identified at the inclusion visit, on VAS (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Quality of Life evaluation by the patient
Time frame: Before (Day 1, Visit 1), and after 28 (Visit 3) consecutive days of products' application
Filling by the patient of a 13-questions questionnaire about their quality of life related to their feet condition.
Global soothing effect evaluation on feet
Time frame: After the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The global soothing is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no relief/no soothing effect to 100 mm = complete relief/total soothing effect)
Intensity of pruritus/itchiness on feet
Time frame: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of pruritus intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no itching or pruritus at all, to 100 mm = extreme itching, unbearable)
Intensity of tingling on feet
Time frame: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of tingling intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tingling sensation, to 100 mm = intense tingling, very uncomfortable)
Intensity of tightness on feet
Time frame: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of tightness intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tightness at all, to 100 mm = extreme tightness, uncomfortable)
Intensity of pain on feet
Time frame: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
The evolution of pain intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no pain at all, to 100 mm = extreme pain, debilitating)
Skin hydration
Time frame: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Skin capacitance is assessed instrumentally by an expert, on the selected foot of each subject
Standardized photographs of the target fissure of each subject to visually assess the evolution of the target fissure.
Time frame: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Cosmetic satisfaction and perceived effect evaluation questionnaire
Time frame: After the first application (Day 1, Visit 1), and after 5 (Visit 2), 15 (at home) and 28 (Visit 3) consecutive days of products' application
Filling by the patient of a subjective evaluation questionnaire considering their cosmetic acceptability, and perceived efficacy towards the investigational/comparator product
Standardized photograph of the selected foot of each subject is taken for illustrative purposes
Time frame: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Compliance of the subject to the product
Time frame: During the entire course of the study, from inclusion visit (Day 1), to the end-of-study visit (Day 28).
Subjects fill in a subject diary (daily log) during the course of the study to record their compliance to the product.
Global assessment of the tolerance
Time frame: At the end of the study (after 28 consecutive days of products' twice-daily application), or premature withdrawal
Global assessment of the tolerance is assessed by the investigator for each subject at the end of the study considering all individual adverse events and their characteristics, based on a 5-point scale (from excellent tolerance to bad tolerance).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV5075A MF6793 and CO5075A in people with Diabetic Foot Xerosis, run by Pierre Fabre Dermo Cosmetique at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerosis intensity on both feet with XAS (Xerosis Assessment Scale) (time frame: Before (Day 1 Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.