Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis
This study is currently recruiting participants.
Verified April 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01012713
First received: November 10, 2009
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Stable Plaque Psoriasis |
Drug: Clobex Spray Drug: Vectical Ointment Procedure: Excimer Laser |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Open-Label Clinical Trial to Test Efficacy and Safety of Combination of Clobex® Spray With Excimer Laser Therapy [Photomedex XTRAC ® Velocity] in the Treatment of Generalized Plaque Psoriasis Followed by Maintenance With Topical Vectical® Ointment |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- The primary endpoint will be the percentage of patients achieving PASI-75 response at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary endpoint will be the percentage of patients achieving PASI-75 at weeks 4 and 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- A tertiary endpoint will be the percentage of patients achieving PASI-90 at weeks 4, 8, and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Open-Label Treatment
All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser
|
Drug: Clobex Spray
Clobex Spray BID for Weeks 1-4 and weeks 9-12
Drug: Vectical Ointment
Vectical ointment BID for weeks 5-8 and 9-12
Procedure: Excimer Laser
Laser treatment for weeks 1-6 study and as needed for patients with less than PASI-75 response thereafter.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Subject is known, or suspected of being unable to comply with the study protocol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012713
Contacts
| Contact: Tina Bhutani, MD | 415-476-4701 | tinabhutanimd@gmail.com |
| Contact: John Koo, MD | 415-476-4701 | john.koo@ucsfmedctr.org |
Locations
| United States, California | |
| UCSF Psoriasis and Skin Treatment Center | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: Tina Bhutani, MD 415-476-4701 tinabhutanimd@gmail.com | |
| Contact: John Koo, MD 415-476-4701 john.koo@ucsfmedctr.org | |
| Principal Investigator: John Koo, MD | |
| Sub-Investigator: Tina Bhutani, MD | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | John Koo, MD | UCSF Department of Dermatology |
| Study Director: | Tina Bhutani, MD | UCSF Department of Dermatology |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01012713 History of Changes |
| Other Study ID Numbers: | Perfect Storm |
| Study First Received: | November 10, 2009 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Psoriasis Excimer Laser Clobex |
Vectical clobetasol spray calcitriol Generalized plaque type psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Calcitriol Clobetasol Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013