Status:
COMPLETED
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Vitiligo
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet B (NB-UVB) phototherapy, in patients with nonsegmental vitiligo. Afamelano...
Detailed Description
Vitiligo is the most common depigmentation disorder. A commonly used treatment is phototherapy with narrow-band ultraviolet B irradiation (NB-UVB). Further therapeutic approaches are desired and curre...
Eligibility Criteria
Inclusion
- for double-blind phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement
- for open label phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 10% to 50% of total body surface involvement
- Vitiligo involving the head and neck
- Stable or slowly progressive vitiligo over a 3-month period
- Aged 21 years or more
- Willing and able to comply with the conditions specified in this protocol and study procedures, in the opinion of the Investigator
- Provided written Informed Consent prior to the performance of any study-specific procedure
Exclusion
- Extensive leukotrichia, in the opinion of the Investigator
- Previous treatment with NB-UVB light or other light source within 6 weeks prior to the Screening Visit
- Patient not responsive to previous NB-UVB light treatment, defined as a patient who had undergone at least 20 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator
- Previous topical treatment for vitiligo, including topical immunomodulators (e.g. corticosteroids, calcineurin inhibitors), within 4 weeks prior to the Screening Visit
- 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 photosensitivity disorders
- Claustrophobia
- Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator
- Any current skin disease that may have interfered with the study evaluation
- Female who was pregnant (confirmed by positive β-human chorionic gonadotropin (HCG) pregnancy test) or lactating
- Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives or diaphragm plus spermicide or intrauterine device) during the treatment phase (7 months) and for a period of three months thereafter - except if abstinence from intercourse was practiced
- Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who was not using adequate contraceptive measures, as described above
- Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
Key Trial Info
Start Date :
June 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04525157
Start Date
June 6 2014
End Date
June 6 2016
Last Update
September 22 2023
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