NCT00476801

Brief Summary

The purpose of this investigation is to evaluate the effectiveness of an investigational device which is similar in appearance to a "tanning bed" but which emits ultraviolet irradiation of a specific wavelength known as UVA1. This device has not been approved by the FDA for general use in this country, as yet, but it has been used quite successfully in Europe for several years in treating such conditions as scleroderma, keloids, and other fibrosing conditions of the skin. Your participation in this study may yield important information regarding the safety and effectiveness of this form of light therapy for the treatment of these skin conditions which, at present, are difficult to treat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2001

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2001

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

May 18, 2007

Last Update Submit

July 8, 2015

Conditions

SclerodermaKeloidsOther Fibrosing Conditions

Keywords

UVA1sclerodermakeloidslight therapymorphea

Outcome Measures

Primary Outcomes (1)

  • Plaque thickness, plaque hardness, patient mobility

    28 weeks

Secondary Outcomes (1)

  • Levels of collagen and mmp induction

    28 weeks

Study Arms (2)

UVA1 irradiation

EXPERIMENTAL

The dose and scheduling will be similar to those being successfully used in Germany: up to 130J/cm2 from a UVA1 Sellamed irradiation device (German manufactured UVA1 light emitting device) with irradiations up to 5 times per week for up to 14 weeks on one side of the face. Then a cross-over treatment an equal length of time.

Device: German manufactured UVA1 light emitting device

Control

NO INTERVENTION

No treatment on the opposite side of the face as the UVA1 treatment for up to 14 weeks. Then a cross-over treatment an equal length of time.

Interventions

German manufactured UVA1 light emitting deviceDEVICE

The UVA1 dose will be up to 130 J/cm2.

UVA1 irradiation

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 10-80 years
  • Clinical diagnosis of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and other related conditions associated with altered dermal matrix.
  • At least two areas of comparable thickness/induration, one on each side, or one large sclerotic lesion that can be divided in half for UVA1 and sham UV therapy.
  • No disease states or physical conditions which would impair evaluation of the test site.
  • Willing and able to receive UVA1 as directed in the protocol, make evaluation visits, and follow protocol restrictions.
  • Signed, written, witnessed, informed consent form.
  • Must live within driving distance of Ann Arbor, Michigan.

You may not qualify if:

  • History of photosensitivity.
  • UVA1 irradiation hypersensitivity in a UVA1 photo-provocation test.
  • Pregnant or nursing women.
  • Involved in an investigational study within the previous 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109-0314, United States

Location

MeSH Terms

Conditions

Scleroderma, DiffuseKeloidScleroderma, Localized

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesCollagen DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sewon Kang, MD

    University of Michigan hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 22, 2007

Study Start

July 1, 2001

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

US(1)