Goal of study: The goal of this study is to investigate the effectiveness of tea tree oil gel on the treatment of mild to moderate facial seborrheic dermatitis in comparison with placebo.
Study protocol: This study is a double-blind, one center, randomized vehicle-controlled clinical trial (Phase 1).
Patients with seborrheic dermatitis admitted to Skin Diseases Research Center, Qazvin univercity of medical sciences.
Inclusion criteria: patients with mild-to-moderate facial seborrheic dermatitis diagnosis, age 18 to 45 years old.
Exclusion criteria: pregnant or breastfeeding women; people under 18 or over 45 years, patients with active, localized, or systemic infection, use of products for seborrheic dermatitis or systemic steroids within the last two weeks ,known allergy to lotions or moisturizers .
Sample size: 27 patients in each group
Intervention: The groups will be treated topically with tea tree oil gel, three times per day for one month.
Intervention time: October-december 2013
Primary outcome: evaluation of seborrheic dermatitis symptoms
Secondry outcome: adverse effect
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072314117N1
Registration date:2013-08-18, 1392/05/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Akram Beheshti
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
abeheshti@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the effectiveness of tea tree oil gel on the treatment of mild to moderate facial seborrheic dermatitis in comparison with placebo
Public title
To investigate the effectiveness of tea tree oil gel on the treatment of mild to moderate facial seborrheic dermatitis in comparison with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with mild-to-moderate facial seborrheic dermatitis diagnosis, age 18 to 45 years old.
Exclusion criteria: pregnant or breastfeeding women; people under 18 or over 45 years, patients with active, localized, or systemic infection, use of products for seborrheic dermatitis or systemic steroids within the last two weeks ,known allergy to lotions or moisturizers .
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Qazvin University of Medical Sciences Ethic Committee
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Postal code
Approval date
2012-06-19, 1391/03/30
Ethics committee reference number
28/20/5996
Health conditions studied
1
Description of health condition studied
seborrhoeic dermatitis
ICD-10 code
L21.8
ICD-10 code description
seborrhoeic dermatitis
Primary outcomes
1
Description
Improvement of seborrheic dermatitis symptoms
Timepoint
After 2 weeks intervention and after 4 weeks intervention
Method of measurement
Clinical examination and comparison with previous conditions
Secondary outcomes
1
Description
Adverse effect
Timepoint
After 2 weeks intervention and after 4 weeks intervention
Method of measurement
Clinical examination and comparison with previous conditions
Intervention groups
1
Description
Intervention group: the groups will be treated topically with tea tree oil gel, three times per day for one month.
Category
Treatment - Drugs
2
Description
Control group: Base gel without drug substances
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Clinic of Boo-Ali Sina Hospital
Full name of responsible person
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeed Asefzadeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
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, Qazvin 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
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Akram Beheshti
Position
Assistant Professor, Department of Dermatology
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
abeheshti@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Akram Beheshti
Position
Assistant Professor, Department of Dermatology
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
Postal code
Phone
+98 28 1336 0084
Fax
Email
abeheshti@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Akram Beheshti
Position
Assistant Professor, Department of Dermatology
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)