Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO (Rapid Vitiligo)

This is an interventional treatment trial for Vitiligo Read More

Inclusion Criteria:

• Diagnosis of non-segmental vitiligo affecting at least 10% of BSA since at least 3 months.
• Patient requiring a treatment by UVB
• For both female of childbearing potential and male patients: Use of an effective contraceptive method during the study period (see Annex 5 for details)
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
• Able to adhere to the study visit schedule and other protocol requirements
• Patient registered to the French Social Security

Exclusion Criteria:

1. Segmental or mixed vitiligo
2. Other than vitiligo, history of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
3. Any condition which would place the subject at unacceptable risk if he/she were to participate in the study.
4. Any condition that confounds the ability to interpret data from the study.
5. Pregnant or breast feeding, pregnancy urinary tests will be performed (see Annex 5 for details about pregnancy testing and contraception)
6. History of allergy to any component of apremilast
7. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
8. Active substance abuse or a history of substance abuse within 6 months prior to Screening
9. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening.
10. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence)
11. Evidence of skin conditions that would interfere with clinical assessments
12. Topical therapy within 2 weeks of randomization
13. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
14. Prior treatment with apremilast
15. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
16. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives,
17. Patients assessed to be uncooperative
18. Participants in other clinical studies
19. Vulnerable people: pregnant or breast-feeding women (an urinary pregnancy test will be realized in every visit), minors, adults under guardianship or guardianship, deprived of freedom
20. Patient with a rare hereditary disease such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
21. Patient with severe renal insufficiency