Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis

NCT01012713 | Completed Phase 4 Results

• 1 other identifier: Perfect Storm
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the combination of Clobex® spray with excimer laser therapy as the initial treatment of generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The study will be conducted in three distinct periods, namely Period A, Period B, and Period C, each of 4 weeks duration. During Period A (weeks 1 through 4), patients will use Clobex® spray twice daily along with excimer laser treatments twice weekly with the Photomedex XTRAC® Velocity machine. The goal of Period A is to achieve Psoriasis Area Severity Index (PASI) 75 in 100% of patients within four weeks. During Period B (weeks 5 through 8), patients would be treated with topical Vectical® twice daily. Thus, there is a steroid-free interval during which patients will not be using Clobex® spray. The goal of Period B is to maintain the patient's response using only non-steroid options. During Period C of the study, patients will use Clobex® spray BID and Vectical® BID. Period C (weeks 9 through 12) will be a "booster" period in which the goal is to see if 100% of patients can achieve Psoriasis Area Severity Index (PASI) 90-100. Regarding excimer laser therapy: all patients will be receiving excimer laser therapy twice weekly for the first 6 weeks of the study (up to the halfway point) which is 12 excimer laser treatments. At that point, only those patients achieving \<Psoriasis Area Severity Index (PASI)75 response will continue to receive twice weekly excimer laser treatments for the remaining 6 weeks of the study.

Conditions

Chronic Stable Plaque Psoriasis

Keywords

Psoriasis; Excimer; Laser; Clobex; Vectical; clobetasol spray; calcitriol; Generalized plaque type psoriasis

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.

  12 weeks

Secondary Outcomes (2)

• The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.

  8 weeks

• A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.

  12 weeks

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser

Drug: Clobex Spray; Drug: Vectical Ointment; Procedure: Excimer Laser

Interventions

Clobex Spray DRUG

Clobex Spray BID for Weeks 1-4 and weeks 9-12

Open-Label Treatment

Vectical Ointment DRUG

Vectical ointment BID for weeks 5-8 and 9-12

Open-Label Treatment

Excimer Laser PROCEDURE

Laser treatment for weeks 1-6 study and as needed for patients with less than PASI-75 response thereafter.

Open-Label Treatment

Eligibility Criteria

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

You may qualify if:

• Male or female subjects 18 years of age of older
• Subjects should have ≥ 10%, but not more than 20% total body involvement of stable plaque type psoriasis.
• Subjects must have BMI \< 30 and weigh less than 250lbs
• Subjects must have Fitzpatrick Skin Type II or above (see Attachment A)
• Subjects must be able to discontinue any topical therapy (other than emollients) or received UVB phototherapy 2 weeks prior to starting the study.
• Subjects must be able to discontinue any biologic or systemic agents or oral psoralen with ultraviolet A 4 weeks prior to starting the study.
• Subject is able to complete the study and to comply with study instructions.
• Subject is capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
• Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis

You may not qualify if:

• Subject is younger than 18 years of age.
• Subject has less than 10% or greater than 20% body surface involvement of his/her psoriasis.
• History of known or suspected intolerance to any of the ingredients of the investigational study product.
• Subject has a photosensitivity disorder (such as lupus, etc.) or a history of clinically significant photosensitivity.
• Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's psoriasis.
• Subject is not willing to discontinue topical treatment (other than emollients) or UVB phototherapy for 2 weeks prior to starting the study
• Subject is not willing to discontinue biologic or systemic agents or oral psoralen with ultraviolet A for 4 weeks prior to starting the study.
• Subject has psoriatic involvement only on the hands, feet, or scalp.
• Subject has been diagnosed with unstable or non-plaque forms of psoriasis, including guttate, erythrodermic, exfoliative, or pustular psoriasis.
• Subject has a history of keobnerization phenomenon
• Subject has keloids or past history of keloid formation
• Subject has melanoma or past history of melanoma
• Subject has active (cutaneous) invasive non-melanoma skin cancer (NMSC)
• Subject is determined not be a candidate for phototherapy by the investigator
• Subject has used other investigational drugs within 4 weeks prior to the study

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Lasers, Excimer

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Dr. John Koo
• Organization: University of California San Francisco

john.koo@ucsfmedctr.org

4154764701

Study Officials

• John Koo, MD

  UCSF Department of Dermatology

  PRINCIPAL INVESTIGATOR

• Tina Bhutani, MD

  UCSF Department of Dermatology

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 13, 2009
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 18, 2015
• Results First Posted: June 18, 2015

Record last verified: 2015-06

Locations

US (1)