Comparision of Therapeutic effects of the herbal anti acne formulation (Acdine gel, Tea Tree Oil 5%) and topical clindamycin in mild acne vulgaris treatment
Compare Therapeutic Effects of Acidine Gel Formulation with 5% Tea Tree Oil and Topical Clindamycin in the Treatment of Acne Vulgaris
Design
Patients treated with Akdin gel containing 5% tea tree oil and patients treated with Clindamycin gel daily 2 times
Settings and conduct
In this study, 60 patients aged 15-30 years with mild acne vulgaris were selected from among patients referring to dermatology clinic of Sina Hospital in Tabriz. Accidentally, 30 patients of Akdin gel containing tea tree oil were 5% and 30 others Clindamycin gel will be given twice a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) patients with mild acne with an average age of 30-15 years
2) Patients with up to 10 inflammatory lesions (just papules or pustules) and lack of nodules, cysts or scars
3) Not having other inflammatory diseases involving the face
4) Not having other acne exacerbatory systemic diseases, such as Cushing's syndrome, PCOS, adrenal hyperplasia, inherited immune deficiency, steroid acne and acne rash
5) Patients who have not used oral or topical anticancer drugs during the past month
6) Patient satisfaction to participate in the study
Exclusion criteria:
1) Age under 15 and over 30 years
2) Pregnant and lactating women
3) Persons who are vulnerable and have mental disabilities
4) Having systemic illness or other facial skin diseases
5) Use of topical or systemic steroid
6) Use of oral or topical anti-acne medication over a recent month
7) Having seborrheic skin
Intervention groups
Patients treated with Akdin gel containing 5% tea tree oil and patients treated with Clindamycin gel daily 2 times
Main outcome variables
Reduce the number of inflammatory and non-inflammatory lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120524009844N7
Registration date:2019-06-25, 1398/04/04
Registration timing:registered_while_recruiting
Last update:2019-06-25, 1398/04/04
Update count:0
Registration date
2019-06-25, 1398/04/04
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of Therapeutic effects of the herbal anti acne formulation (Acdine gel, Tea Tree Oil 5%) and topical clindamycin in mild acne vulgaris treatment
Public title
Therapeutic effects of the herbal anti acne formulation gel Tea Tree Oil in mild acne vulgaris treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with mild acne with an average age of 30-15 years
Patients with up to 10 inflammatory lesions (just papules or pustules) and lack of nodules, cysts or scars
Not having other inflammatory diseases involving the face
Not having other acne exacerbatory systemic diseases, such as Cushing's syndrome, PCOS, adrenal hyperplasia, inherited immune deficiency, steroid acne and acne rash
Patients who have not used oral or topical anticancer drugs during the past month
Have Patient Satisfaction to Participate in the Study
Exclusion criteria:
Age under 15 and over 30 years
Pregnant and lactating women
Persons vulnerable and mentally impaired
Having systemic illness or other facial skin diseases
Use of topical or systemic steroids
Oral or topical anti-acne medication over a recent month
Having seburic skin
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized randomization will be carried out with a simple randomization unit using the Radlist software. This allocation will be placed by a person independent of the study in the envelope and will remain hidden until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment assessor and the statistical analyst will not be aware of the allocation of intervention until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Approval date
2016-06-16, 1395/03/27
Ethics committee reference number
IR.TBZMED.REC.1395.274
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
Reduce the number of inflammatory and non-inflammatory lesions
Timepoint
Every 7 days
Method of measurement
By Visiting and examination with doctor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acadin group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina teaching hospital
Full name of responsible person
Dr. Mehdi Amirnia
Street address
Azadi Street
City
tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ataa Mahmoudpour
Street address
Azadi st
City
tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
mehamir46@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Amirnia
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi st
City
tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Email
mehamir46@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
amirniam@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Mir Haji
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi st
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Email
Roya.mirhaji@gmai.lcom
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
En All data will be shared after being unidentified.
When the data will become available and for how long
At any time
To whom data/document is available
It will be free for everyone.
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Email: mehamir46@gmail.com Dr Mehdi Amirnia 09143113577 Dermatology Department - Sina Hospital- Azadi Street- Tabriz
What processes are involved for a request to access data/document
The Request will be checked, then data will be sent by Email in 1 month