Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix

NCT00129428 | Completed Phase 1

• 1 other identifier: Derm 447
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare or related conditions.

Conditions

Keloid; Scleroderma, Localized; Acne Keloidalis; Scars; Granuloma Annulare

Keywords

UVB; keloid; scleroderma; acne keloidalis nuchae; scars; granuloma annulare

Outcome Measures

Primary Outcomes (1)

• Improvement in appearance of keloids (hypertrophic scars), scleroderma, acne keloidalis nuchae,old burn scars, granuloma annulare, and related conditions with altered dermal matrix

  Subjects will be evaluated at weeks 1, 2, 4, and then at monthly intervals until the end of the study.

Secondary Outcomes (2)

• Assays to be performed on biopsy specimens may include any or all of the following assays: in situ hybridization, immunohistologic analysis, in situ zymography, radioimmunoassay, and Western blot analysis

  Assays will be performed after specimen collection

• Photographs will also be taken.

  At baseline and at end of the study.

Study Arms (1)

UVB Irradiation

EXPERIMENTAL

A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.

Procedure: UVB Irradiation

Interventions

UVB Irradiation PROCEDURE

A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.

UVB Irradiation

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In good general health and between 10-80 years of age.
• Willing and able to receive UVB, as directed in the protocol; make evaluation visits; follow protocol restrictions; and sign a written, witnessed, informed consent form.
• Have a clinical diagnosis of keloid, scleroderma, old burn scars, granuloma annulare, or acne keloidalis nuchae.
• No disease states or physical conditions that would impair evaluation of the test site
• Must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

You may not qualify if:

• Have a history of photosensitivity (development of hives or bumps with exposure to light) or experience hypersensitivity in a UVB photo-provocation test.
• Have participated in another investigational study in the past 4 weeks, taken oral therapy for skin condition, or on photosensitizing medications.
• Pregnant, nursing, or planning to become pregnant during the study.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Keloid; Scleroderma, Localized; Acne Keloid; Cicatrix; Granuloma Annulare; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Acneiform Eruptions; Folliculitis; Hair Diseases; Necrobiotic Disorders; Granuloma; Scleroderma, Systemic

Study Officials

• John J Voorhees, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Dermatology, Medical School Department

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 11, 2005
• Study Start: August 1, 2002
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

US (1)