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Chronic Stable Plaque Psoriasis

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

Sponsored by University of California, San Francisco

About this trial

Last updated 10 years ago

Study ID

Perfect Storm

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 11 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Male or female subjects 18 years of age of older

2. Subjects should have ≥ 10%, but not more than 20% total body involvement of stable plaque type psoriasis.

3. Subjects must have BMI < 30 and weigh less than 250lbs

4. Subjects must have Fitzpatrick Skin Type II or above (see Attachment A)

5. Subjects must be able to discontinue any topical therapy (other than emollients) or received UVB phototherapy 2 weeks prior to starting the study.

6. Subjects must be able to discontinue any biologic or systemic agents or oral psoralen with ultraviolet A 4 weeks prior to starting the study.

7. Subject is able to complete the study and to comply with study instructions.

8. 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.

9. 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

No

Exclusion Criteria

1. Subject is younger than 18 years of age.

2. Subject has less than 10% or greater than 20% body surface involvement of his/her psoriasis.

3. History of known or suspected intolerance to any of the ingredients of the investigational study product.

4. Subject has a photosensitivity disorder (such as lupus, etc.) or a history of clinically significant photosensitivity.

5. 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.

6. Subject is not willing to discontinue topical treatment (other than emollients) or UVB phototherapy for 2 weeks prior to starting the study

7. Subject is not willing to discontinue biologic or systemic agents or oral psoralen with ultraviolet A for 4 weeks prior to starting the study.

8. Subject has psoriatic involvement only on the hands, feet, or scalp.

9. Subject has been diagnosed with unstable or non-plaque forms of psoriasis, including guttate, erythrodermic, exfoliative, or pustular psoriasis.

10. Subject has a history of keobnerization phenomenon

11. Subject has keloids or past history of keloid formation

12. Subject has melanoma or past history of melanoma

13. Subject has active (cutaneous) invasive non-melanoma skin cancer (NMSC)

14. Subject is determined not be a candidate for phototherapy by the investigator

15. Subject has used other investigational drugs within 4 weeks prior to the study

16. Subject is known, or suspected of being unable to comply with the study protocol

Locations

Location

Status