Comparison of theraputic effects of Tea Tree Oil nanoemulsion gel containing adapalene with commercial form of adapalene gel for the treatment of acne vulgaris
The aim of this study was to compare the therapeutic effect of topical Tea Tree Oil nanoemulsion containing adapalene, with commercially available adapalene gel in treatment of mild to moderate Acne Vulgaris. In this regards, randomized double-blind clinical trial, 160 patients with Acne Vulgaris will be allocated into two groups. Pregnant and breast feeding women, children younger than 15 years, patients with severe acne or previous anti-acne therapy in recent 2 weeks and patients using acne-inducing drugs will be excluded. Groups will be prescribed to two groups under study for a 12-week period. Inflammatory and non-inflammatory lesions will be counted, and the side effects assessed and recorded monthly during the study period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090223864N1
Registration date:2015-10-19, 1394/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-19, 1394/07/27
Registrant information
Name
Amir Amani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 218899111824
Email address
aamani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of theraputic effects of Tea Tree Oil nanoemulsion gel containing adapalene with commercial form of adapalene gel for the treatment of acne vulgaris
Public title
The treatment of Acne Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of mild to moderate Acne Vulgaris (up to 10 comedons, papular and/or pustular lesions).
Exclusion criteria: pregnant and lactating women, children younger than 15 years old, severe cases of acne (existence of nodules and cysts), receiving anti acne during two weeks prior to study, taking acne creating drugs such as oral or local steroids, spirnolactone, finasteride. Patient with diabetes mellitus, endocrine disorder.
Age
From 15 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-07-29, 1394/05/07
Ethics committee reference number
94-01-87-28505-159333
Health conditions studied
1
Description of health condition studied
acne vulgaris
ICD-10 code
L70
ICD-10 code description
acne vulgaris
Primary outcomes
1
Description
Inflammatory and noninflammatory lesions
Timepoint
Baseline and after 4,8, and 12 weeks
Method of measurement
counting lesions using manual lens
Secondary outcomes
1
Description
side effect
Timepoint
Baseline and after 4, 8, and 12 weeks
Method of measurement
case report form
Intervention groups
1
Description
Topical tea tree oil nanoemulsion loaded 0.1% adapalene gell, one times daily on the clean skin for 3 months
Category
Treatment - Drugs
2
Description
Topical adapalene gell 0.1%, one times daily on the clean skin for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Amir-Hoshang Ehsani
Street address
Vahdat Eslami St., Tehran ,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences
Street address
Keshavarz Blvd., Qods Street; Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Roqiye Najafi-Taher
Position
Ph.D Candidate of Medical Nanotechnology
Other areas of specialty/work
Street address
Eastern side of Tehran University, 88, Italia St,The School of Advanced Technologies in Medicine (SATiM),Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8899 1118
Fax
Email
r-najafitaher@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Dr. Amir Amani
Position
Associate Professor
Other areas of specialty/work
Street address
Eastern side of Tehran University of Medical sciences, 88E, Italia St, The school of Advance Technologies in Medicine(SATiM), Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8899 1117
Fax
+98 21 8899 1117
Email
aamani@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roqiye Najafi-Taher
Position
Ph.D Candidate of Medical Nanotechnology
Other areas of specialty/work
Street address
Eastern side of Tehran University, 88, Italia St,The School of Advanced Technologies in Medicine (SATiM),Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
r-najafitaher@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)