Vitiligo Skin and Connective Tissue Diseases
Conditions
Interventions
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) t
Sponsors
Vimela Therapeutics, Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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. Has received any ultraviolet (UV)-B phototherapy, has had psoralen-UV-A (PUVA) treatment, or excimer laser within 4 weeks prior to the pretreatment period 18. Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per the discretion of the investigator, including drugs that cause photosensitivity in the UVB range or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening 19. Has had excessive sun exposure, is planning outdoor activities with long-hours exposure to the sun, has used tanning booths within 4 weeks prior to the pretreatment period or is not willing to minimize natural and artificial sunlight exposure during the study 20. Has a known history of clinically significant drug or alcohol abuse in the last year prior to the pretreatment period 21. Has a known or suspected allergy to the active ingredient (afamelanotide) in VIM-004 Gel or any other component of the investigational medicinal product. 22. Is institutionalized because of legal or regulatory order 23. Has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics and latex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be assessed by: 1. Local tolerability assessment measured using a dermal response scale, sensation scale, and pain Numeric Rating Scale (NRS) and evaluating adverse events during all study visits during the treatment period 2. Recording vital signs and performing physical examinations weekly throughout the 12-week treatment period and at 4 weeks post-treatment 3. Evaluating clinical laboratory results at week 6 during the treatment period and at 4 weeks post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of VIM-004 measured using pharmacokinetic methods on Day 1, Day 8 and Week 12 Exploratory outcome measures: 1. Repigmentation measured using planimetry and image analysis weekly 2. Repigmentation percentage for target lesions measured using the Vitiligo Extent Score for a Target Area (VESTA) weekly | — |
Countries
Mauritius
Contacts
Public ContactClaire Bouix-Peter
Outcome results
None listed