Can a pill plus light therapy restore skin color in vitiligo?
NCT ID NCT03036995
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether the drug apremilast, taken as a pill twice daily, combined with narrowband UVB light therapy can help restore skin color in people with widespread vitiligo. 80 adults with stable or slowly progressing vitiligo covering at least 10% of their body took part. The main goal was to see if the combination leads to more repigmentation than light therapy alone after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apremilast (a pill that reduces inflammation and may help restore skin color) combined with narrowband UVB light therapy
- What this could lead to
- If it works, this could point toward a new treatment option that helps restore skin color in people with widespread vitiligo.
- What could go wrong
- This is a small, early-phase study (80 people) with a short treatment period. The results may not apply to everyone, and the drug can cause side effects like nausea or headache.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
80 people
The number who actually took part.
- Started
-
Mar 2017
- Finished
-
Nov 2019
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Vitiligo are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU de Nice - Dermatologie - Hôpital Archet
Nice, Alpes-Maritimes, 06, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a skin cream bring back color to faces with vitiligo?
- Skin markers may reveal how light therapy fights vitiligo
- Can Real-World data unlock better skin disease care?
- New ointment aims to restore skin color in vitiligo
- Skin microbes linked to vitiligo and immunotherapy reactions in melanoma patients
- New vitiligo registry aims to uncover disease trends in 2,500 patients