This study is a randomized, double-blind, control trial on patients > 12 years old Who referred to dermatology clinic or office with mild to moderate acne vulgaris.If the Volunteers taking the medication for acne in the past 2 months or allergy to medicine used in the study Can not be included in the study. At first randomly divided into two groups containing aloe vera and licorice gel or clindamycin 1% gel. Both drugs are consumed locally bedtime and after washing with antibacterial soap. The duration of study 8 weeks and Volunteers 4 times visit. Baseline, the end of the first week, the fourth week and eighth weeks. In addition to the grading acne at each visit, the total lesion count (TLC) and acne severity index (ASI) per person calculated and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021412438N17
Registration date:2016-02-16, 1394/11/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-16, 1394/11/27
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Plants
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gel containing of aloe vera gel and licorice extract on mild to moderate acne vulgaris
Public title
The effect of gel containing of aloe vera and licorice on acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with mild to moderate acne, defined as GAGS scale, who were not satisfied with their previous acne therapies participated in the study after giving written informed consent
Exclusion criteria:pregnancy or lactation; had received topical anti acne therapy two months before or during the study or any systemic therapy with antibiotics; had a skin disease that might interfere with the diagnosis or evaluation of their hyper pigmentation; were known to be allergic or sensitive to any of the study medications or their components
Age
From 12 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized based on table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
IR.KAUMS.REC.1394.149
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
acne grading
Timepoint
Baseline and End-of-trial
Method of measurement
Global Acne Grading System(GAGS)
2
Description
acne severity
Timepoint
Baseline, the end of the first and fourth weeks, end of the study
Method of measurement
acne severity index(ASI)
3
Description
total lesion count
Timepoint
Baseline, the end of the first and fourth weeks, end of the study
Method of measurement
total lesion count( TLC)
Secondary outcomes
empty
Intervention groups
1
Description
intervention: topical use herbal gel after washing with antibacterial soap every night at bedtime for two months
Category
Treatment - Drugs
2
Description
control: topical use Clindamycin after washing with antibacterial soap every night at bedtime for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr R.Talaee office
Full name of responsible person
Dr Rezvan Talaee
Street address
City
Kashan
2
Recruitment center
Name of recruitment center
Shahid Beheshti hospital dermatology clinic
Full name of responsible person
Dr Rezvan Talaee
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Science
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan university of Medical Science, Kashan
City
Kashan
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 Kashan University of Medical Science
Proportion provided by this source
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
Kashan University of Medical Sciences
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mohsenta44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr rezvan talaie
Position
Dermatologist
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
00
Fax
Email
R_talaee2007@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Km. 44 of Kashan - Delijan Rd, Mashhad-e- Ardehal Kashan
City
Kashan
Postal code
Phone
00
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)