Determine the effect of aloe vera gel on the severity of lesions in acne patients
Design
Controlled clinical trial with a parallel group design
Settings and conduct
This study is done in the skin clinic. Samples will be selected from patients with acne vulgaris.
Participants/Inclusion and exclusion criteria
The inclusion criteria included:Age between 18 and 40 years and satisfaction participate in the study. Exclusion criteria included: discontinuation from the study and allergic to Aloe Vera gel.
Intervention groups
Group 1 (intervention): topical application of Aloe vera plant gel, once a week for two weeks
Group 2 (placebo): Topical use of distilled water, once a week for two weeks
Main outcome variables
Severity of acne lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130731014229N9
Registration date:2019-04-08, 1398/01/19
Registration timing:registered_while_recruiting
Last update:2019-04-08, 1398/01/19
Update count:0
Registration date
2019-04-08, 1398/01/19
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Aloe Vera gel and placebo on the severity of lesions in patients with acne vulgaris
Public title
The effect of Aloe vera gel on the severity of acne lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 to 40 years
Aloe Vera gel insensitivity
Exclusion criteria:
Do not use Aloe Vera gel more than once
Cancellation of participation in the study
Pregnancy and lactation
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to quadruple blocks A, A, B, B in random groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyzer do not know which groups are located. The samples in the intervention and control group did not know whether they received the placebo or the main drug. The statistician will receive questionnaires as anonymously and in form A and B, and he does not know which are intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی اراک
Street address
Basij Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ARAKMU.REC.1397.378
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
total lesion count
Timepoint
Measuring the severity of acne lesions at the beginning of the study (before the intervention) and 7, 14 days after the start of use of Aloe Vera gel
Method of measurement
Global Acne Grading system or GAGS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the medications prescribed by the doctor, topical application of 5 mm of natural aloe vera plant gel for 15 days a day
Category
Treatment - Drugs
2
Description
Control group: For the control group, distilled water is used as the drug
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic Dr. Mirnezami
Full name of responsible person
Hadi Jafarianesh
Street address
Abasabad Ave.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad ََArjomandzadegan
Street address
Deputy of Research and Technology, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 38 1969 3345
Email
nurse_science@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarianesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 34173503
Email
nurse_science@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Arak University of Medical Sciences
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available