Vitiligo Clinical Trial | U.S. Dermatology Partners

Vitiligo Clinical Trial Study Description

U.S. Dermatology Partners is conducting a clinical study to compare the efficacy and safety of SCENESSE & NB-UVB light versus NB-UVB Light alone in patients with vitiligo.

Brief Summary

The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Vitiligo

Condition or Disease

Vitiligo

Vitiligo Clinical Trial Study Design

Design Details

Primary Purpose : Treatment

Allocation : Randomized

Interventional Model : Parallel Assignment

Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
Experimental: Afamelanotide and NB-UVB Light	Drug: Afamelanotide and NB-UVB Light Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.
Other: NB-UVB Light	Procedure: NB-UVB Light Patients will receive NB-UVB light twice per week for 20 weeks.

Participant Group/Arm

Intervention/Treatment

Experimental: Afamelanotide and NB-UVB Light

Drug: Afamelanotide and NB-UVB Light

Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.

Other: NB-UVB Light

Procedure: NB-UVB Light

Patients will receive NB-UVB light twice per week for 20 weeks.

Eligibility Criteria

Ages Eligible for Study:	12 Years and older (Child, Adult, Older Adult )
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Inclusion Criteria

Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥0.3 of the body and F-VASI≥0.3
Stable or active vitiligo
Aged 12 or more
Fitzpatrick skin types IV-VI

Exclusion Criteria

Fitzpatrick skin types I-III
Extensive leukotrichia
Treatment with NB-UVB phototherapy in the last three months prior to study start
Allergy to afamelanotide or the polymer contained in the implant
Any other treatment for vitiligo within four weeks prior to the Screening Visit
History of melanoma or lentigo maligna
History of dysplastic nevus syndrome
Any malignant skin lesions
Presence of severe hepatic disease or hepatic impairment
Female who is pregnant or lactating
Female of child-bearing potential not using adequate contraceptive measures
Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures
Use of any prior and concomitant therapy which may interfere with the objective of the study

ADDITIONAL DETAILS

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Vitiligo (SCENESSE NB-UVB Study)

Vitiligo Clinical Trial Study Description

Brief Summary

Condition or Disease

Vitiligo Clinical Trial Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Application for Clinical Trials

ACTIVE TRIALS

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