A comparison of wound healing between Arnebia euchroma ointment (a herbal drug) and Vaseline after laser resurfacing in bilateral face acne scar patients
This is a single-center, clinical trial on both sides of the face (Face-splits). The aim of this study is to compare the efficacy of herbal drug named as Arnebia euchroma ointment (AEO) and Vaseline on wound healing from CO2 fractional laser resurfacing in bilateral face acne scar patients. In this study 40 men and women aged 20 to 65 years - with bilateral acne scar in face- are eligible for enrollment. Pregnant women; and patients received Isotretinoin or topical drugs simultaneously are excluded. After CO2 fractional laser resurfacing, subjects apply Vaseline and AEO 4 times daily (morning, midday, evening, and bedtime) to opposite sides of the face for one week. Clinical assessment of recovery (erythema, edema, crusts, and erosions) is assessed using 0 to 3 point
Visual scoring systems. In addition,clinical photography was taken on days 2, 4 and 7.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109067499N1
Registration date:2013-01-10, 1391/10/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-10, 1391/10/21
Registrant information
Name
Jale Aliaslmamghany
Name of organization / entity
Medical Facualty of Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 4116
Email address
aliasl@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Medical faculty of Shahed University
Expected recruitment start date
2012-07-10, 1391/04/20
Expected recruitment end date
2012-12-10, 1391/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of wound healing between Arnebia euchroma ointment (a herbal drug) and Vaseline after laser resurfacing in bilateral face acne scar patients
Public title
Effect of Arnebia euchorma on post Fractional Laser wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men and women aged 20 to 65 years with bilateral facial acne scar which treat by Laser fractional co2 and have burning after Laser. Exclusion criteria: Pregnant women; Isotretinoin user; use of topical drugs simultaneously
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Tehran-Qom highway
City
Tehran
Postal code
3319118651
Approval date
2012-07-09, 1391/04/19
Ethics committee reference number
148489
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20.2
ICD-10 code description
Burn of second degree of head and neck
Primary outcomes
1
Description
Wound healing
Timepoint
Post procedure and days 2 , 4 , 7
Method of measurement
Visual scoring systems ( 0=none, 1= mild, 2= moderate, 3= severe) and digital photographs are taken
In intervention group, subjects apply Arnebia euchroma ointment 4 times daily and clinical assessment of recovery (erythema, edema, crusts, and erosions) are assessed using 0 to 3 point visual scoring systems and digital photographs are taken from two sides of the face on post procedure and days 2 , 4 and 7
Category
Treatment - Drugs
2
Description
In control group, subjects apply Vaselin 4 times daily and clinical assessment of recovery (erythema, edema, crusts, and erosions) are assessed using 0 to 3 point visual scoring systems and digital photographs are taken from two sides of the face on post procedure and days 2 , 4 and 7
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser Research center of Shohadae Tajrish Hospital
Full name of responsible person
Behroz Barikbin
Street address
Shahrdari St., Tajrish Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Dr Heshmaty
Street address
No. 29, Abdollahzade St., Keshavarz Blvd
City
Tehran
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, Shahed University
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
Iranian Traditional Medicine Group of medical faculty of Shahed university
Full name of responsible person
Jale Aliaslmamghany
Position
Resident (phd) of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No. 29, Abdollahzade St., Keshavarz Blvd
City
Tehran
Postal code
1415635111
Phone
+98 21 8896 3849
Fax
+98 21 8896 6310
Email
aliasl@shahed.ac.ir , jaliasl@yahoo.com
Web page address
www.shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical faculty of Shahed University
Full name of responsible person
Jale Aliaslmamghany
Position
Resident(phd) of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No. 29, Abdollahzade St., Keshavarz Blvd
City
Tehran
Postal code
1415635111
Phone
+98 21 8896 3849
Fax
+98 21 8896 6310
Email
aliasl@shahed.ac.ir, jaliasl@yahoo.com
Web page address
www.shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Medical Faculty, Shahed University
Full name of responsible person
Jale Aliaslmamghany
Position
Resident(phd) of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No. 29, Abdollahzade St., Keshavarz Blvd
City
Tehran
Postal code
1415635111
Phone
+98 21 8896 3849
Fax
+98 21 8896 6310
Email
aliasl@shahed.ac.ir , jaliasl@yahoo.com
Web page address
www.shahed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)