Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitil… (NCT01430195) | Clinical Trial Compass
CompletedPhase 1
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)
United States56 participantsStarted 2011-06
Plain-language summary
The purpose of this study is to look at the efficacy of afamelanotide, when combined with narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo. Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to reducing frequency and doses of NB-UVB.
Who can participate
Age range18 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 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
* Previous treatment with NB-UVB within 6 months prior to the Screening Visit
* Patient not responsive to previous NB-UVB treatment, defined as a patient who has undergone at least 30 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator
* Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anesthetic 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
* H…
What they're measuring
1
Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores