NCT01732965

Brief Summary

To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

November 13, 2012

Last Update Submit

February 22, 2017

Conditions

Vitiligo

Keywords

VitiligoPhototherapyPhotochemotherapy

Outcome Measures

Primary Outcomes (1)

  • Determine the quantity of repigmentation

    Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.

    6 months

Secondary Outcomes (1)

  • Determine the quality of repigmentation.

    Study initiation, 3 months and 6 months.

Study Arms (2)

NB-UVB phototherapy

PLACEBO COMPARATOR

NB-UVB alone

Other: Phototherapy

phototherapy and photochemotherapy

EXPERIMENTAL

NB-UVB and PUVA

Other: Phototherapy and Photochemotherapy

Interventions

PhototherapyOTHER
NB-UVB phototherapy
Phototherapy and PhotochemotherapyOTHER
phototherapy and photochemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vitiligo affecting more than 15% body surface area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Dermatology

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

PhototherapyPhotochemotherapy

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCombined Modality TherapyDrug Therapy

Study Officials

  • Iltefat Hamzavi, MD

    Henry Ford Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Physician

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 26, 2012

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)