Status:
UNKNOWN
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
Lead Sponsor:
Clinuvel, Inc.
Conditions:
Vitiligo
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.
Eligibility Criteria
Inclusion
- Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50%
- Stable face vitiligo with F-VASI of at least 0.1%
- Stable or slowly progressive vitiligo over a 3-month period
- Fitzpatrick skin types IV-VI
- Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming
Exclusion
- Patients with segmental vitiligo
- Fitzpatrick skin types I-III
- Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming.
- Previous topical treatment for vitiligo
- Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant
- History of melanoma or lentigo maligna
- Any current skin disease that may interfere with the study evaluation
- Presence of severe hepatic disease or hepatic impairment
- Renal impairment
- History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation
- Female who is pregnant or lactating
- Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter
- Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above
- Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
- Use of any other prior and concomitant therapy which may interfere with the objective of the study
- Subjects assessed as not suitable for the study in the opinion of the Investigator
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05210582
Start Date
October 11 2022
End Date
August 1 2023
Last Update
February 9 2023
Active Locations (1)
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1
CLINUVEL Investigational site
Detroit, Michigan, United States, 48202