Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NCT01382589) | Clinical Trial Compass
CompletedPhase 2
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
15 participantsStarted 2011-09
Plain-language summary
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement
* Stable or slowly progressive vitiligo over a 3-month period
* Aged 18 or more
* Fitzpatrick skin types III-VI
* Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator
* Providing written Informed Consent prior to the performance of any study-specific procedure
Exclusion criteria:
* Fitzpatrick skin types I-II
* Vitiligo involving the hands and feet only
* Extensive leukotrichia, in the opinion of the Investigator
* Vitiligo of more than 5 years duration
* 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
* Previous treatment with topical immunomodulators (corticosteroids, calcineurin inhibitors) for vitiligo within 4 weeks prior to the Screening Visit
* History of photosensitivity disorders
* Claustrophobia
* History of photosensitive lupus
* Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator
* History of melanoma or lentigo maligna
* History of dysplastic nevus syndrome
* Any malignant skin lesions
* Any skin disease that may interfere with the study evaluation
* Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinica…
What they're measuring
1
To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo