Effect of Aloe vera topical gel combined with tretinoin in treatment of mild and moderate acne vulgaris: a randomized, double-blind, placebo controlled trial
The aim of this study is to compare the efficacy and safety of the combination of tretinoin cream (0.05%) and Aloe vera topical gel (50%) with tretinoin and vehicle on mild to moderate acne vulgaris patients. The patients will not satisfied with their previous acne therapies. Patients were excluded if they had an uncontrolled systemic disease; had received topical antiacne therapy two months before or during the study or any systemic therapy with antibiotics 30 days before or during the study.
The randomized, double blind, prospective, placebo-controlled 8-week trial will evaluate inflammatory and noninflammatory lesion counts and tolerability in 60 subjects with mild to moderate acne vulgaris (Global Acne Grading System scale).
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2012070810203N2
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Majid Saeedi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3082
Email address
msaeedi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-04-03, 1389/01/14
Expected recruitment end date
2012-03-08, 1390/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aloe vera topical gel combined with tretinoin in treatment of mild and moderate acne vulgaris: a randomized, double-blind, placebo controlled trial
Public title
Effect of Aloe vera gel on acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:the score of acne was determined based on GAGS scale and patients with mild to moderate acne vulgaris enter to study; and a urinary pregnancy test was performed; the cases have not received any medication.
Exclusion criteria: Patients with an uncontrolled systemic disease; patients had received topical antiacne therapy two months before or during the study or any systemic therapy with antibiotics 30 days before or during the study; were known to be allergic or sensitive to any of the study medications or their components; had previously been treated with systemic retinoids; or were pregnant, or planning to become pregnant, and lactating.
Age
From 11 years old to 40 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
Used
Assignment
Parallel
Other design features
-
Secondary Ids
1
Registry name
Traditional and complementary research center
Secondary trial Id
90-129
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences ethics committee
Street address
Moallem sq., Chancellator of research
City
Sari
Postal code
Approval date
2012-02-08, 1390/11/19
Ethics committee reference number
90-129
Health conditions studied
1
Description of health condition studied
Mild to moderate acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
acne vulgaris
Primary outcomes
1
Description
lesion count
Timepoint
0, 2, 4, 8 th. week
Method of measurement
lesion scoring
2
Description
adverse reactions (scaling, oedema, erythema, burning, and itching)
Timepoint
2, 4, 8 th. week
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Tretioin cream once a day (at night) and Aloe vera gel 50% (twice in day)
Category
Treatment - Drugs
2
Description
Tretinoin cream once a day (at night) and Placebo (twice in day) for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dermatology, Tooba Clinic, Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
18th. km of Khazar road, Faculty of Pharmacy, P.O.Box: 48175-861
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor of Research, Mazandaran University of Medical Sciences
Full name of responsible person
Prof. A. Enayati
Street address
Moallem sq., Chancellor of Research Building
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor of Research, Mazandaran 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
Department of pharmaceutics
Full name of responsible person
Majid Saeedi
Position
Professor
Other areas of specialty/work
Street address
18th. km of Khazar road, Faculty of pharmacy, Mazandaran University of Medical Sciences, P.O.Box 48175-861
City
Sari
Postal code
Phone
+98 15 1354 3082
Fax
Email
MSaeedi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of pharmaceutics
Full name of responsible person
Majid Saeedi
Position
Professor
Other areas of specialty/work
Street address
18th. km of Khazar road, Faculty of Pharmacy, Mazandaran University of Medical Sciences, P.O.Box 48175-861
City
Sari
Postal code
Phone
+98 15 1354 3082
Fax
Email
MSaeedi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Pharmaceutics
Full name of responsible person
Majid Saeedi
Position
Professor
Other areas of specialty/work
Street address
18th. km of Khazar road, Faculty of Pharmacy, Mazandaran University of Medical Sciences, P.O.Box 48175-861
City
Sari
Postal code
Phone
+98 15 1354 3082
Fax
+98 15 1354 3084
Email
MSaeedi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)