Efficacy and Safety of Barphani Ointment in patients suffering from Chronic plaque Psoriasis

Phase 2

Conditions: Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue

Recruitment & Eligibility

Inclusion Criteria

1. Male or Female Subjects in the age group of 18 to 60 years, both

inclusive.

2. Subjects with confirmed diagnosis of plaque psoriasis since at least 6

months

3. Subjects must have active plaque psoriasis for atleast 10 % of body surface area.

4. Subjects with plaque psoriasis having PASI score >10

5.Subjects of female gender or non-pregnant, non-lactating females. A

urine pregnancy test is required for all female subjects of childbearing

potential unless subject has had a hysterectomy, tubal ligation, or is > 2

years postmenopausal.

6.Subjects willing to follow the procedures as per the study protocol and

voluntarily sign an informed consent form.

Exclusion Criteria

1.Subjects who have received systemic treatment for Psoriasis such as

Methotrexate or Cyclosporine therapy or any conventional systemic treatment

for more than 4 weeks one month prior to screening in the study.

2.Any laser dermatological procedure, 4 weeks prior to screening in this study

3.Known cases of Severe/Chronic hepatic or renal disease.

4.Known case of any active malignancy.

5. Subjects giving history of significant cardiovascular event < 12 weeks prior

to recruitment.

6.Subjects having known chronic, contagious infectious disease, such as

active tuberculosis, Hepatitis B or C, or HIV.

7. Subjects participating currently or 1 month prior to recruitment in any other

clinical study

8.Known hypersensitivity to any of the ingredients used in study drug

9.Pregnant and Lactating females.

10. Any other condition due to which patients are deemed to be unsuitable by

the investigatorâ??s opinion for reason(s) not specifically stated in the exclusion

criteria.

Primary Outcome Measures

Name	Time	Method
1.Assessment of changes in PASI Score to measure severity and extend of psoriasis. <br/ ><br>2.Assessment of Clinical Photographic changes in psoriasis lesions (Scaling, Intensity and Thickness). <br/ ><br>Timepoint: 90 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Assessment of Quality of life on Dermatology Life Quality Index (DLQI) <br/ ><br>2.Assessment of change in Overall Disease Severity (ODS) Score i.e. treatment success. <br/ ><br>3.Assessment of Changes in Pruritus Score on the Visual Analogue Scale (VAS) <br/ ><br>4.Assessment of relapse of Psoriasis after 30 days of cessation of treatment <br/ ><br>5Assessment of Adverse Drug Reaction <br/ ><br>6. Global assessment of overall safety of BARPHANI Ointment <br/ ><br>7.subjectâ??s Global Assessment for overall change at the end of study. <br/ ><br>Timepoint: 90 days