Status:
COMPLETED
ERASE VITILIGO Early Repigmentation Approach for Stopping the Evolution of VITILIGO Prospective Multicentric Interventional Study With Blinded Evaluation
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Vitiligo
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
Vitiligo affects 1 to 2% of worldwide population and has a demonstrated impact on the quality of life. Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt ...
Eligibility Criteria
Inclusion
- 1\. Patients with non-segmental vitiligo. 3 groups of patients will be selected:
- Patients with a long-lasting disease (more than 2 years) and no new or growing lesion since at least 2 years
- Patients with a long-lasting disease (more than 2 years) and with at least one new lesion since less than 6 months
- Patients developing for the first-time vitiligo lesions with all the lesions no older than 6 months 2. ≥ 18 and \<35 years to have a homogeneous distribution of age between the three groups, as 80% of vitiligo cases start before the age of 30.
- 3\. Patient with at least one lesion of more than 2 cm² not located on the face, hands or feet.
- 4\. Patient needing a treatment with oral minipulses of steroids and phototherapy 5. For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed.
- 6\. Affiliation to a social security system 7. Signed informed consent
Exclusion
- 1\. Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration.
- 2\. Segmental or mixed vitiligo 3. Vitiligo located only on face, hands and feet 4. Exposure to solar or artificial UV during the months before inclusion 5. Concomitant use of topical or systemic immunosuppressive medication or steroids 6. Patients suffering from photodermatosis or taking photosensitive drugs 7. Personal history of skin cancer. 8. Patients with diabetes, high blood pressure, osteoporosis or any other contra-indication to the use of systemic steroids.
- 9\. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom 10. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04843059
Start Date
June 1 2021
End Date
August 18 2025
Last Update
September 2 2025
Active Locations (2)
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1
CHU de Nice
Nice, alpes maritimes, France, 06001
2
CHU Bordeaux
Bordeaux, France, 33440