A phase Ib/IIa, proof of concept, double-blind, placebo-controlled, intraindividual randomized study to evaluate the safety, tolerability, and preliminary efficacy of VIM-004 gel in participants with vitiligo
Vitiligo
All eligible participants will be randomized using the randomization list provided by an unblinded statistician. The randomization list will define the treatment (VIM-004 Gel or VIM-004 Placebo Gel) to be allocated to each treatment area (Area 1 and Area 2) per participant (intra-individually). The pre-defined list will ensure that treatment assignment is unbiased, and this will be concealed from participants and blinded site staff. The randomization schedule will be produced by the unblinded staff using SAS 9.4. The unblinded statistician will not take part in any of the study-related processes. Two application areas between 9-25 cm2 will be defined. Participants will start with a narrow-band (NB)-UVB pretreatment period for 30 days in all application areas. These areas will be randomised in a 1:1 ratio on Day 1 to VIM-004 Gel and VIM-004 Placebo Gel, with NB-UVB treatment. VIM-004 Gel or VIM-004 Placebo Gel will be applied topically once a day on the 2 application areas. The application will be repeated for a total of 5 consecutive days per week for 12 weeks. During the treatment period, all application areas will also receive NB-UVB treatment 3 times per week. There will be a 4-week follow-up period.
1. Aged 18 to 70 years 2. Clinical diagnosis of stable nonsegmental vitiligo lesions 3. Fitzpatrick's skin phototype of >=4 4. Has nonsegmental vitiligo lesions that can accommodate 2 application areas between 9-25 cm2 of comparable VESTA score in easy-to-treat areas 5. Has nonsegmental vitiligo lesions with a maximum of 10% white hairs in the 2 selected application areas 6. Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 7. Involved in sexual intercourse that could lead to pregnancy: must agree to use a highly effective contraceptive method from >= 4 weeks prior to the pretreatment period and until >=2 weeks after the last study product application 7. Willing to participate and is capable of giving informed consent 8. Willing and able to comply with all study procedures and must be available for the duration of the study
1. Has active form(s) of inflammatory skin disease or evidence of skin condition that would interfere with evaluation of vitiligo or response to treatment 2. Has active acute or chronic skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals or antifungals within 2 weeks prior to Day 1 or superficial skin infections within 1 week prior to Day 1 3. Has the presence of any tattoos, scratches, open sores, excessive hair, or skin damage in the application areas 4. Has active forms of other hypopigmentation 5. Is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the time of the study 6. Is known to have immune deficiency or is immunocompromised. 7. Has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1 8. Had a major surgery within 8 weeks prior to Day 1 or had a major surgery planned during the study 9. Has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would put the participant at undue risk or interfere with the interpretation of study results 10. Has a positive result for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus 11. Has used permanent depigmentation treatment for vitiligo and/or other types of pigmentation disorders at any time 12. Has used systemic treatments that could affect vitiligo within 8 weeks prior to the pretreatment period or within 5 half-lives, whichever is longer 13. Has used topical medicated treatment that could affect vitiligo 14. Has used herbal medications with unknown properties or known beneficial effects for vitiligo within 1 week of the pretreatment period 15. Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to the pretreatment period 16. Is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to the pretreatment period 17. H