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

Phase 1

• Conditions: Vitiligo; MedDRA version: 21.1Level: PTClassification code: 10047642Term: Vitiligo Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-507470-40-00
• Lead Sponsor: Clinuvel Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-06
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Male and female participants with a confirmed diagnosis of generalized vitiligo in the face and body, Stable or active vitiligo diagnosed for at least three months, Fitzpatrick skin types IV-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-III, 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, Any skin disease that may interfere with the study evaluation, 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 leukotrichia, Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, Allergy to afamelanotide or the polymer contained in the implant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of SCENESSE® and NB-UVB compared to NB-UVB alone in repigmentation of vitiligo;Secondary Objective: To determine the safety of SCENESSE® and NB-UVB light treatment in participants with vitiligo, To evaluate the efficacy of SCENESSE® and NB-UVB compared to NB-UVB alone in repigmentation of vitiligo, To compare the maintenance of pigmentation achieved with SCENESSE® and NB-UVB versus NB-UVB alone in participants with vitiligo;Primary end point(s): Percentage of participants achieving re pigmentation in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Time to onset of repigmentation;Secondary end point(s):Time to onset of repigmentation of face