Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical… (NCT01012713) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis
United States30 participantsStarted 2010-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. 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.
âś“. Subjects must have BMI \< 30 and weigh less than 250lbs
âś“. Subjects must have Fitzpatrick Skin Type II or above (see Attachment A)
âś“. Subjects must be able to discontinue any topical therapy (other than emollients) or received UVB phototherapy 2 weeks prior to starting the study.
âś“. Subjects must be able to discontinue any biologic or systemic agents or oral psoralen with ultraviolet A 4 weeks prior to starting the study.
âś“. Subject is able to complete the study and to comply with study instructions.
âś“. 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.
Exclusion criteria
What they're measuring
1
The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.
âś•. Subject has less than 10% or greater than 20% body surface involvement of his/her psoriasis.
âś•. History of known or suspected intolerance to any of the ingredients of the investigational study product.
âś•. Subject has a photosensitivity disorder (such as lupus, etc.) or a history of clinically significant photosensitivity.
âś•. 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.
âś•. Subject is not willing to discontinue topical treatment (other than emollients) or UVB phototherapy for 2 weeks prior to starting the study
âś•. Subject is not willing to discontinue biologic or systemic agents or oral psoralen with ultraviolet A for 4 weeks prior to starting the study.
âś•. Subject has psoriatic involvement only on the hands, feet, or scalp.