Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT01430195
• Date of registration: 18/08/2011
• Primary sponsor: Clinuvel Pharmaceuticals Limited
• Public title: Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) CUV102
• Scientific title: Proof of Concept Study to Compare Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Nonsegmental Vitiligo
• Date of first enrolment: June 2011
• Target sample size: 56
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01430195
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Henry Lim, MD
• Affiliation: Henry Ford Hospital, 3031 W. Grand Blvd., Suite 800, Detroit, MI 48202, USA

Key inclusion & exclusion criteria

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

- 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

- Any evidence of organ dysfunction or deviation from normal in clinical or laboratory
determinations judged to be clinically significant by the Investigator

- History of systemic or psychiatric disease judged to be clinically significant by the
Investigator and which may interfere with the study evaluation

- Female who is pregnant (confirmed by positive ß-HCG pregnancy test), are lactating

- Female of child-bearing potential (pre-menopausal, not surgically sterile) not using
adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide,
intrauterine device) during the trial and for a period of three months thereafter

- Sexually active man with a partner of child-bearing potential not using barrier
contraception during the trial and for a period of three months hereafter

- Participation in a clinical trial for an investigational agent within 30 days prior
to the Screening Visit

- Use of any prior and concomitant therapy which may interfere with the objective of
the study, including drugs that cause photosensitivity or skin pigmentation within 60
days prior to the Screening Visit

- Subjects assessed as not suitable for the study in the opinion of the Investigator



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Vitiligo

Intervention(s)

Drug: Afamelanotide

Procedure: Narrow-Band UVB Light Treatment

Primary Outcome(s)

Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores [Time Frame: 6 months]

Secondary Outcome(s)

Maintenance of pigmentation using the VASI and VETF scores [Time Frame: 12 months]

Quality of life using the Dermatology Life Quality Index (DLQI) [Time Frame: 6 months]

Short term safety of both treatments: Routine laboratory assessments - Full body anterior and posterior photography - Vitiligo lesion photography - Examination of the skin and oral mucosa and digital photography - Ophthalmologic examination [Time Frame: 6 months]

Time to onset of repigmentation of full body, face, trunk and extremities [Time Frame: 6 months]

Vitiligo biopsies assessments (optional, selected sites only) [Time Frame: 6 months]

Secondary ID(s)

CUV102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors