Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis
| Status: | Terminated |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | January 2010 |
| End Date: | October 2011 |
A Comparison of Treatment of Psoriasis With Acitretin or Tazarotene Gel 0.1% and Active or Sham Treatments With the 308 nm Excimer Laser
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene
0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.
The primary objective of this study is to compare the improvement of psoriatic plaques with
and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded
fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will
be the comparison between the change in NPF score of plaques treated with excimer laser and
those treated with sham treatment.
The secondary objectives are to compare the number of excimer light treatments and time
necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with
acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to
combinations of the study treatments.
0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.
The primary objective of this study is to compare the improvement of psoriatic plaques with
and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded
fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will
be the comparison between the change in NPF score of plaques treated with excimer laser and
those treated with sham treatment.
The secondary objectives are to compare the number of excimer light treatments and time
necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with
acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to
combinations of the study treatments.
Inclusion Criteria:
- Must give written informed consent
- Must be at least 18 years old
- Must have been diagnosed with stable plaque type psoriasis covering between 1 and 5%
BSA
- NPF-PS ≥8 (based additive scores averaged over all lesions for erythema, scale, and
thickness range of score = 0-5)
- No systemic or phototherapy in the 4 wks prior to entering the study
- No topical therapy other than emollients (no corticosteroids, vitamin D analogs,
vitamin A analogs) in the 2 wks prior to entering the study
- Women on tazarotene gel must not be pregnant nor planning to become pregnant during
the study and must be on two forms of birth control
- Subjects known to not tolerate oral acitretin at 25 mg/day and women of child-bearing
potential may be enrolled and treated with topical tazarotene gel 0.1%
Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria
exist at the time of enrollment:
- Unstable disease
- Only treatable sites are in intertriginous areas or on face
- Subjects unable to tolerate frequency of visits
- NPF-PS severity score <8 additive score of erythema, scale, and thickness, averaged
over all lesions
- History of inability to tolerate topical tazarotene 0.1% gel and or acitretin 25
mg/day
- Women of childbearing potential are excluded from the actretin arm of the study.
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