A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients with Vitiligo
- Conditions
- Vitiligo
- Interventions
- Procedure: NB-UVB Light
- Registration Number
- NCT06109649
- Lead Sponsor
- Clinuvel, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1
- Stable or active vitiligo
- Aged 12 or more
- Fitzpatrick skin types III-VI
- Fitzpatrick skin types I-II
- 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 30 days 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
- Extensive tattoos
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afamelanotide and NB-UVB Light Afamelanotide and NB-UVB Light - NB-UVB Light NB-UVB Light -
- Primary Outcome Measures
Name Time Method Percentage of patients achieving T-VASI 50 on the body From baseline to Day 140 Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
- Secondary Outcome Measures
Name Time Method Time to onset of repigmentation of full body From baseline to first documented occurrence of TVASI25, assessed up to Day 140 Measured using T-VASI 25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100)
Time to onset of repigmentation of face From baseline to first documented occurrence of FVASI25, assessed up to Day 140 Measured using F-VASI 25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100).
Percentage of patients achieving VASI 50 on the face From baseline to Day 140 Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet From Day 140 to 308 Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Percentage of patients maintaining VASI 50 on facial lesions From Day 140 to 308 Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Percentage of patients achieving VASI 25/75/90 on the body From baseline to Day 140 Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Percentage of patients achieving VASI 25/75/90 on the face From baseline to Day 140 Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Percentage change in pigmentation on body surface area measured by the VASI scoring system From baseline to Day 308 Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Percentage change in pigmentation on facial surface area measured by the VASI scoring system From baseline to Day 308 Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Trial Locations
- Locations (2)
CLINUVEL site
🇬🇧Manchester, United Kingdom
CLINUVEL Site
🇺🇸Cedar Park, Texas, United States