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

Primary Purpose

Vitiligo

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Afamelanotide

NB-UVB

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, depigmentation, phototherapy, non-segmental vitiligo

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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
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 β-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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Afamelanotide + NB-UVB

Arm B: NB-UVB alone

Arm Description

Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 6 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total)

Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)

Outcomes

Primary Outcome Measures

To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo

Time to onset of repigmentation of full body, face, trunk and extremities Pigmentation by VASI and VETF Maintenance of pigmentation Dermatology Life Quality Index (DLQI) Safety of the treatment will be assessed by: For selected study sites, immunomodulatory assessment Full body anterior and posterior photography Vitiligo lesion photography Examination of the skin and oral mucosa and digital photography Ophthalmologic examination

Secondary Outcome Measures

Maintenance of pigmentation achieved

Full Information

NCT ID

NCT01382589

First Posted

June 7, 2011

Last Updated

March 21, 2013

Sponsor

Clinuvel Pharmaceuticals Limited

1. Study Identification

Unique Protocol Identification Number

NCT01382589

Brief Title

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

Acronym

NSV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinuvel Pharmaceuticals Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).

Detailed Description

The investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-MSH). The earliest described function of alpha-MSH is its ability to stimulate melanin synthesis in the skin and therefore stimulate pigmentation. Vitiligo is the most common depigmentation disorder. Interventions in the treatment of vitiligo include phototherapy with narrow-band (NB) ultraviolet B (UVB) irradiation (NB-UVB). The purpose of this study is to look at the efficacy of afamelanotide, when combined with narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo. Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to reducing frequency and doses of NB-UVB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

Keywords

vitiligo, depigmentation, phototherapy, non-segmental vitiligo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Afamelanotide + NB-UVB

Arm Type

Experimental

Arm Description

Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 6 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total)

Arm Title

Arm B: NB-UVB alone

Arm Type

Active Comparator

Arm Description

Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)

Intervention Type

Drug

Intervention Name(s)

Afamelanotide

Other Intervention Name(s)

CUV1647

Intervention Description

NB-UVB phototherapy with or without subcutaneous, bioresorbable Afamelanotide 16 mg implants, contained in a poly(D,L-lactide-co-glycolide) implant core released over 7-10 days following implantation

Intervention Type

Device

Intervention Name(s)

NB-UVB

Intervention Description

NB-UVB light therapy 3-times per week, for total of 72 treatments

Primary Outcome Measure Information:

Title

To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Maintenance of pigmentation achieved

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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 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 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 β-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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanni Leone, MD

Organizational Affiliation

San Gallicano Dermatological Institute, Photodermatology Unit, Roma, ITALY

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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