Vitiligo (SCENESSE NB-UVB Study)

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.

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‚Č•0.3 of the body and F-VASI‚Č•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