Clinical trail of tea tree oil nanoemulsion gel against clindamysin gel in treatment of acne
Design
randomization: equalized blocks, 174 samples will be needed. the phase 3 of the clinical trial will be used
Settings and conduct
First, the aims of the study will explained. On the first day and after 6 weeks, the patients will be visited and the total number of papules, pustules and comedones will be counted. After 3 weeks they will be called and any possible side effects will be asked.
The patients will be given a handout to write down the adverse effects including the date of observing the adverse effect.
Sampling will be done in Emam Reza Clinic or the office
Participants/Inclusion and exclusion criteria
Patients with mild to medium acne
inclusion criteria: age 15-30 years, filling the consent form, no use of drugs for the last 14 days
exclusion criteria: pregnancy, lactation, hormone diseases, physical disabilities
Leaving the study: adverse side effects, tendency of the patients
Intervention groups
1. group receiving the nanoemulsion gel
2. group receiving the clindamycin gel
Main outcome variables
Acne severity index, Skin inflammation, total number of acne
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150902023864N4
Registration date:2021-10-27, 1400/08/05
Registration timing:prospective
Last update:2021-10-27, 1400/08/05
Update count:0
Registration date
2021-10-27, 1400/08/05
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
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of gel of tea tree oil nanoemulsion against clindamycin gel in treatment of acne
Public title
Gel of tea tree oil nanoemulsion in treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No use of any medicine (including body building agents) in the last 14 days
Age: 15-30 years
To conceal the data, all the packs will be the same. each pack will contain a label so that the dispenser and the prescriber will not be aware of the contents. The sampling will be performed using Permuted Block Randomization. Group A:
To do so, using the online software "Random number generator", block of treatment groups A and B will be generated.
Group A: Tea tree oil nanoemulsion gel, Group B: Clindamycin gel
Here is example of the first few blocks:
AABB
ABBA
ABAB
etc.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Same packaging will be used. A code will be written on the packs. secretary will give the packs to the patients using a randomized list. The practitioner and the statistician will not be aware of the pack contents.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of north khorasan university of medical sciences
Street address
N0. 91, shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694765
Approval date
2021-10-19, 1400/07/27
Ethics committee reference number
IR.NKUMS.REC.1400.114
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
Inflammatory and noninflammatory lesions
Timepoint
First day- 6th week
Method of measurement
counting lesions using manual lens
Secondary outcomes
1
Description
side effects
Timepoint
first day and 6th week
Method of measurement
questionnaire (any possible side ffects)
Intervention groups
1
Description
Intervention group: gel of tea tree oil nanoemulsion: twice daily- after washing the affected area with soap and drying the skin, the medicine will be applied topically. Then, the area should not be washed for two hours. The treatment will continue for two weeks, then the patient will be visited again.
Category
Treatment - Drugs
2
Description
Control group: Clindamycin gel (commercial formulation available in the market)- twice daily- after washing the affected area with soap and drying the skin, the medicine will be applied topically. Then, the area should not be washed for two hours. The treatment will continue for two weeks, then the patient will be visited again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Ali Nazari
Street address
Safa street, Emam Reza Hospital
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3151 3333
Email
amani76@gmail.com
2
Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Hamid Sooregi
Street address
Madar building, Shariati street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3224 7298
Email
amani76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Ahmad Hashemi
Street address
Dolat Boulevard
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3151 0000
Email
amani76@gmail.com
Grant name
Grant code / Reference number
4000067
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Amani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
shahriar strett
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 7157
Email
amani76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Amani
Position
acadmic member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 90, Shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 21 3229 7182
Email
amani76@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Amani
Position
acadmic member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 90, Shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 21 3229 7182
Email
amani76@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data potentially may be shared
When the data will become available and for how long
Nearly in 3 years
To whom data/document is available
All peaple
Under which criteria data/document could be used
there is no condition
From where data/document is obtainable
they can email the PI
What processes are involved for a request to access data/document