Mechanistically-based Optimization of UV Radiation Therapy in Psoriasis

NCT00470392 | Terminated Results DMC

• 1 other identifier: IMMB-004-06S
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is 1) to determine whether Imiquimod or Steroid pretreatment modifies UVB laser light response resulting in increased cell death compared to UVB laser light alone; 2) to determine if pretreatment of psoriatic lesions with Imiquimod or Steroid prior to UVB laser light exposure selectively effects various T cell functions; 3) to determine clinical results from the Imiquimod/Steroid/UVB laser light and correlate those changes with immuno-histochemical changes in the skin; and 4) to determine if single high dose lesion limited UVB laser light intervention combined with Imiquimod or Steroid influences T cell changes

Conditions

Psoriasis

Keywords

Erythema; optimization; Papule; Plaque; pretreatment; T cells; UVB laser light; psoriasis; topical administration

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Elevated MyxA

  Lesions were treated with either Imiquimod or Clobetasol cream. Lesions were subsequently treated with UVB and biopsied. From the biopsy samples obtained from the Imiquimod arm, quantitative PCR was performed to measure levels of Myx A, an imiquimod response gene.

  Biopsy samples for analysis were taken 1 hour post UVB treatment

Secondary Outcomes (2)

• Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment

  2 weeks after Imiquimod and UVB

• Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2

  Biopsy samples for analysis were taken 1 hour post UVB treatment

Study Arms (2)

Imiquimod

OTHER

Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.

Drug: Imiquimod

Clobetasol

OTHER

Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.

Drug: Clobetasol

Interventions

Imiquimod DRUG

Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.

Also known as: Aldara

Imiquimod

Clobetasol DRUG

Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.

Also known as: Temovate

Clobetasol

Eligibility Criteria

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

You may qualify if:

• The presence of plaque-type psoriasis in areas of the trunk, buttocks, or extremities that are amenable to biopsy and evaluable disease in at least 2 cm target treatment sites separated by 1 cm
• Age 18-80, both genders, all ethnicities
• No contraindications to phototherapy or biopsy procedures
• No topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 1 week prior to the study
• No systemic psoriasis therapy for at least four weeks prior to the study
• Able to give informed consent under IRB approval procedures

You may not qualify if:

• Photosensitivity disorders
• Active untreated diseases or medication usage which may interfere with UVB, wound healing, or immune function
• Hypersensitivity to local anesthetic
• Inability to provide informed consent
• Pregnancy and /or lactating

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (2)

University Hospital Case Medical Center

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Links

• The National Institute of Arthritis, Musculoskeletal, and Skin Diseases website providing fast facts on health topics, including psoriasis

MeSH Terms

Conditions

Psoriasis; Erythema; Plaque, Amyloid

Interventions

Imiquimod; Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.

Results Point of Contact

• Title: Kevin D. Cooper MD
• Organization: Louis Stokes VA Medical Center and University Hospitals Case Medical Center

kevin.cooper@uhhospitals.org

216 844 3111

Study Officials

• Kevin D Cooper, MD

  VA Medical Center-Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2012
• Last Updated: October 5, 2016
• Results First Posted: February 12, 2014

Record last verified: 2016-10

Locations

US (2)