Clinical trials for comparison between the efficacy of the fig fruit extract cream, hydrocortisone ointment and placebo on the severity of skin lesions in children up to 15 years of age with mild to moderate atopic dermatitis
This study is a double-blind, randomized clinical trial (RCTs) to compare the efficacy of extract the fig fruit cream with topical corticosteroid ointment and placebo in children with atopic dermatitis. Forty five children up to 15 years of age with mild to moderate atopic dermatitis who refer to the dermatology clinic at Shohada Hospital and the asthma and allergy clinic at Mofid Hospital will participate in the study. The severity of clinical symptoms of atopic dermatitis must be less than 50 based on the scoring atopic dermatitis index. Patients with severe atopic dermatitis, systemic disease, or immune deficiency disorders are excluded. Moreover, Users of systemic drugs during last 4 weeks or topical drugs during last 2 weeks for atopic dermatitis treatment will be excluded from the study. Eligible patients will be randomized into following groups: fig fruit extract (n=15), hydrocortisone (n=15) and Farabi base cream as a placebo (n=15) by using block randomization method. Each cream is used twice a day for two weeks. After two weeks, the overall severity of symptoms will be evaluated by the scoring atopic dermatitis index. All patients will be re-examined after one month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101419529N1
Registration date:2015-03-11, 1393/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-11, 1393/12/20
Registrant information
Name
Shirin Abbasi
Name of organization / entity
Faculty of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
abbasish931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials for comparison between the efficacy of the fig fruit extract cream, hydrocortisone ointment and placebo on the severity of skin lesions in children up to 15 years of age with mild to moderate atopic dermatitis
Public title
Fig fruit extract cream and hydrocortisone ointment in atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children up to 15 years of age with mild to moderate atopic dermatitis
exclusion criteria:
1- Children with severe atopic dermatitis.
2- Children with systemic disease, other skin disease, immune deficiency or skin infections.
3- Users of systemic drugs during last 4 weeks or topical drugs during last 2 weeks for atopic dermatitis treatment.
4- Patients who do not desired to stay in the study.
Age
From 1 day old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The Fig cream, Hydrocortisone ointment and Farabi base cream were packed in identical tubes which differed only with respect to coding and both patients and clinicians were blinded to the treatment group to maintain the double blind nature of the study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
research/930235/1/281
Health conditions studied
1
Description of health condition studied
Atopic Dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic Dermatitis
Primary outcomes
1
Description
Clinical severity of cutaneous lesions
Timepoint
At baseline, at the end of the treatment course(2 weeks later), one month after the cessation of the treatment
Method of measurement
SCORAD index
Secondary outcomes
1
Description
Recurrence of cutaneous lesions
Timepoint
1 month after the cessation of the treatment
Method of measurement
Physical exam and history taking
Intervention groups
1
Description
Patients in intervention group should use the fig fruit extract cream twice daily for 2 weeks on all cutaneous lesions of the whole body.
Category
Treatment - Drugs
2
Description
Patients in control group should use hydrocortisone ointment twice daily for 2 weeks on all cutaneous lesions of the whole body.
Category
Treatment - Drugs
3
Description
Patients in placebo group should use Farabi base cream twice daily for 2 weeks on all cutaneous lesions of the whole body.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
DR. Mehdi Qaisari
Street address
Qhods Sq. Shahrdari St. Shohada Tajrish Hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Mofid Children Hosp
Full name of responsible person
DR. Mehdi Qaisari
Street address
Mofid Children Hosp. next to the Hoseinie-Ershad, Shariati Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Said Islame
Street address
Ghoreish Building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mashhad University of Medical Sciences