Effect of topical drug made from chamomile and pumpkin on psoriasis plaque improvement

Phase 2

• Conditions: psoriasis.; Psoriasis

• Registration Number: IRCT2016092830030N1
• Lead Sponsor: Vice chancellor for research, Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Main Patients with mild to moderate Psoriasis (less than 10 percent of body surface area); diagnosed by a dermatologist; aged 2-60 years old of both sexes with at least two symmetrical psoriasis plaques in their extensor areas; Discontinuation of topical treatment for at least two weeks prior to the study; Lack of systemic treatment or phototherapy during 4 weeks prior to the study; Absence of skin infections or malignancy in the treatment area; Not using Medications that could Trigger Psoriasis like beta blockers; Taking a written consent form from the patient. Main Exclusion criteria: Lactation; Pregnancy; History of allergy to the active ingredient of the product; History of skin infection or skin malignancy in the treatment area; Allergic reaction to the drug or infection in treatment area; Need to start systemic therapy during the study; Occurrence of events During the study which cause anxiety, Stress or severe mental disturbance in patients; Unwillingness of patients to continue treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scaling, Thickness, Redness. Timepoint: Before treatment and one month later for each lesion. Method of measurement: Compare photos by dermatologist and assign a number from 0 to 8 (0 no symptoms, 2 mild, 4 moderate, 6 severe, 8 very severe) to each of these signs.;PSI score. Timepoint: Before treatment and one month later for each lesion. Method of measurement: The sum of redness, thickness and scaling score.

Secondary Outcome Measures

Name	Time	Method
Photography from lesions. Timepoint: Before treatment and one month later for each lesion. Method of measurement: Canon SX60 HS, with 65x zoom and 21-1365 mm eq lens and resolution 17 Megapixels.;Patient and physician overall estimation of treatment success rate. Timepoint: Before treatment and one month later for each lesion. Method of measurement: At the end of the study, both the dermatologist and patient will determine their estimation of improvement rate in each groups of lesions by assigning a number from 0 to ± 100. These numbers will be analyzed in a qualitative manner: negative number: worsening, 0: unchanged, (0-25 %): mild improvement, [25-50%): moderate improvement), [50-75%): high improvement, [75-100%): very high improvement, 100%: full recovery.;Evaluation of possible side effects of formulation and placebo. Timepoint: Two weeks and a month after treatment. Method of measurement: History taking and photography.