To evaluate the effectiveness of topically applied chamomile–pumpkin semi-solid formulation compared with placebo in the improvement of psoriasis plaque in patients refer to dermatology clinic of Tehran University of Medical Sciences in 2016
Objectives: Psoriasis is a common inflammatory skin disease with chronic and recurrent nature. First line treatment of mild cases, is topical treatment. According to available evidence in the traditional and classical medicine literature about the effect of chamomile and pumpkin in the treatment of inflammatory skin diseases, this study is designed to evaluate the effectiveness of topical formulation made from these two plants on psoriasis plaque.
Design: This study is a prospective, single blinded, intrapatient comparison and phase II trial.
Conduct: The patients randomly use drug and placebo on two symmetrical plaques on left and right sides of their body for one month.
Participants: The population study is 43 patients attending to the dermatology clinic of Tehran University of Medical Sciences with mild to moderate psoriasis with at least two symmetrical plaques on their extensor areas.
Interventions: patients use topical chamomile-pumpkin formulation and placebo on symmetrical plaques.
Main outcome measures: To evaluate response to treatment, photography and estimating the amount of redness, thickness and scaling of the plaques is done before and one month after the treatment. At the end of the study, both patient and physician will determine response to treatment by specifying a number of 0 to 100 for each groups of lesions which will be analyzed in a qualitative manner. The possible side effects of the drug and placebo are recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092830030N1
Registration date:2016-11-05, 1395/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-05, 1395/08/15
Registrant information
Name
Sima Kolahdooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6697 0869
Email address
simakolahdooz@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effectiveness of topically applied chamomile–pumpkin semi-solid formulation compared with placebo in the improvement of psoriasis plaque in patients refer to dermatology clinic of Tehran University of Medical Sciences in 2016
Public title
Effect of topical drug made from chamomile and pumpkin on psoriasis plaque improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Main Inclusion criteria: 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.
Age
From 2 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Tehran university of medical sciences
Street address
Sixth floor, central building of the university, St. Ghods, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.184
Health conditions studied
1
Description of health condition studied
psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
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
2
Description
PSI score
Timepoint
Before treatment and one month later for each lesion
Method of measurement
The sum of redness, thickness and scaling score
Secondary outcomes
1
Description
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
2
Description
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.
3
Description
Evaluation of possible side effects of formulation and placebo
Timepoint
Two weeks and a month after treatment
Method of measurement
History taking and photography
Intervention groups
1
Description
Intervention group: semi-solid formulation (combination of chamomile oil and pumpkin oil in a ratio of 1 to 1) topical treatment twice daily for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Liquid paraffin with 0.1 percent chamomile essence, topical treatment twice daily for 4 weeks