A Phase II, Randomised Pilot Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo - Phase II Vitiligo Pilot Study

CLINUVEL PHARMACUETICALS LTD.0 sites60 target enrollmentMarch 5, 2012

ConditionsSubjects affected by non-segmental vitiligo MedDRA version: 14.1Level: PTClassification code 10062080Term: Pigmentation disorderSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Subjects affected by non-segmental vitiligo
Sponsor: CLINUVEL PHARMACUETICALS LTD.
Enrollment: 60
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 5, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

CLINUVEL PHARMACUETICALS LTD.

Eligibility Criteria

Inclusion Criteria

•Male and female subjects with a confirmed diagnosis of 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
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 40
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 20

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 anaesthetic 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 • Any disorder associated with an immune deficiency eg infections with EBV or CMV • Diagnosed with HIV/AIDS, or Hepatitis B or C •History of melanoma or lentigo maligna • Patients with a family history of melanoma in a first degree relative •History of dysplastic nevus syndrome • History of malignant or pre\-malignant skin lesions • Patients with a large number of nevi or patients having more than 5 atypical nevi •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 Î²\-HCG pregnancy test) or 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