Clinical Evaluation of Film forming spray (FFS)in Patients with Plaque Psoriasis A Prospective Open labelled Split Body Comparative Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the end of 4 weeks.
Study Overview
Brief Summary
Informed consent will be taken from patient before enrollment, A detailed history including any associated medical condition followed by general physical examination will be done to see any abnormal parameters ,After meeting all inclusion criteria ,enrollment will be done and all baseline photographs will be taken, overall severity score & HD PASI will be calculated
patient will be asked to apply film forming spray with steroid ointment on one side and steriod ointment alone on other side for 4 weeks
follow up will be done at week1,week2,week4
at every week OSS & HD -PASI assessment will be done ,at week-4 IAGI,PAGI ,CAS assessment would be done
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •outpatients aged ≥18 years with mild to moderate chronic stable plaque psoriasis affecting ≤10% BSA Patients having at least 2 symmetrical psoriatic lesions that are similar in erythema, induration, and scaling.
- •Target lesions (plaques) diameter ≤5 cm Target lesions (plaques) must have had a total modified HD PASI score of 4 or greater and are within 1 point of each other for each of the 3 parameters (erythema, induration, and scaling) Willing to comply with study procedures, treatments (topical steroid ointment application) and assessments.
Exclusion Criteria
- •Lesion localized to scalp, face, groin area Use of biological therapies/systemic anti-psoriatic treatment (previous 12 weeks).
- •Patients with evidence of a skin disorder other than plaque-type psoriasis, clinically infected psoriasis, and/or skin atrophy in the area of the target lesion.
- •Hypersensitivity to alcohol-based preparation Pregnancy , Lactation Severe renal impairment or severe hepatic disorders Use of topical Anti-psoriatic in last 4 weeks.
Outcomes
Primary Outcomes
To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the end of 4 weeks.
Time Frame: 4 weeks
Secondary Outcomes
- To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the week 1 and week 2.(To assess Change from baseline in the scores for Modified HD PASI (High Discrimination Psoriasis Area and Severity Index) for target lesion at the end of 4 weeks.)
Investigators
Bikash Ranjan Kar
Institute of medical science and sum Hospital