Evaluation of effectiveness of betamethasone lotine 0/1% compared with clotrizone lotion (clotrimazole1% and betamethasone 0/05%) in patients with seborrheic dermatitis of face and scalp
The aim of this study is to evaluate the effect of topical betamethasone lotion 0/1% compared with clotrizone lotion (clotrimazole1% and betamethasone 0/05%) in patients with seborrheic dermatitis of face and scalp referred to Quaem and Emam Reza dermatology clinic, after filling council form randomly will be treated with betamethasone lotion or clotrizone lotion. Our method will be block randomization. All drugs in one pharmacy and with similar bottle with numerical code will be prepared. Patients and physician will be blind about kind of treatment. Instruction is topical use of lotion in symptomatic area twice a day for one month. Severity of disease will be obtained with SDASI. According to this method patients will be examined in first visit and in 2 and 4 week after beginning of treatment and severity of disease will be recorded. Examination will be repeated 4 and 8 week after end of treatment period to evaluate the rate of recurrence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060628291N1
Registration date:2016-06-20, 1395/03/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-20, 1395/03/31
Registrant information
Name
Seyedeh Fatemeh Yaghoubi Al
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2493
Email address
sfya@rayana.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Hamedan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of betamethasone lotine 0/1% compared with clotrizone lotion (clotrimazole1% and betamethasone 0/05%) in patients with seborrheic dermatitis of face and scalp
Public title
Evaluation of effectiveness of betamethasone lotine 0/1% compared with clotrizone lotion (clotrimazole1% and betamethasone 0/05%) in patients with seborrheic dermatitis of face and scalp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients more than 18 years old with seborrheic dermatitis of face and scalp referred to Quaem and Emam Reza dermatology clinics.
Exclusion Criteria:
Patient with systemic disease; Use of topical or systemic treatments of seborrheic dermatitis during 2 previous weeks; Pregnancy and laction; History of allergy to the drugs of this study; HIV infection; Parkinson disease; Using of psyciatric drugs; Other papulo squamus disease (psoriasis, tinea,..).
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Hamedan University of Medical Sciences
Street address
Mahdieh Street, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.UMSHA.REC.1394.174
Health conditions studied
1
Description of health condition studied
Seborrhoeic dermatitis
ICD-10 code
L21
ICD-10 code description
Seborrhoeic dermatitis
Primary outcomes
1
Description
Improvement of erythema scaling and pruritus
Timepoint
2 and 4 weeks after beginning of treatment and 4 and 8 weeks after end of treatment period
Method of measurement
Based on measuring the change of amount of erythema scaling and pruritus
Secondary outcomes
empty
Intervention groups
1
Description
Betamethasone lotine 0/1%
Made in Iran Najo
20 m, 20 ml, twice a day for month in Symptomatic section
Category
Treatment - Drugs
2
Description
Clotrizone lotion (clotrimazole1% and betamethasone 0/05%)
Made in Iran Najo
20 ml, twice a day for month in Symptomatic section
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Quaem Hospital
Full name of responsible person
Seyedeh Fatemeh Yaghoubi Al
Street address
Department of dermatology, Quaem hospital, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Hamedan University of Medical Sciences
Full name of responsible person
Dr saeid Bashirian
Street address
Mahdieh Street, Hamedan University of Medical Sciences
City
Hamedan
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 Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Seyedeh Fatemeh Yaghoubi Al
Position
Resident
Other areas of specialty/work
Street address
Dermatology clinic, Quaem hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 3801 2493
Fax
Email
sfya@rayana.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Seyedeh Fatemeh Yaghoubi Al
Position
Resident of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Quaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 3801 2493
Fax
Email
sfya@rayana.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Akram Sadat Momenzadeh
Position
Bachelor of Biology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3841 0135
Fax
Email
src@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)