Evaluation the effectiveness of Ziziphus spina-christi topical solution plus clindamycin 1% compared with Clindamycin1% plus placebo in mild to moderate acne
The aim of this study is to determine the efficacy of Cedar topical solution on reducing mild to moderate acne vulgaris symptoms in the facial area.
Design
Patients with mild to moderate acne are divided into two intervention and control groups by using Permuted block randomization method. The sample size is 55 in each group. The intervention group received topical cedar solution plus clindamycin 1% and the control group receiving topical placebo plus 1% clindamycin. The investigator and the patients are not aware of any type of treatment and the study is a double blind randomized clinical trial.
Settings and conduct
Patients who come to Behesht Clinic and have inclusion criteria randomly receive a package containing a solution of cedar or placebo, which are similar are similar in physical properties, shapes, colors, and odds, and they the inserted code. Patient and researcher have no information about drug or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 15-45 years old, both men and women
Suffering mild and moderate acne vulgaris in face
Exclusion criteria: pregnancy; lactating; polycystic ovary syndrome; using acnogenic medicines such as corticosteroids; humoral and antipsychotic medicines; other types of acne; skin allergy.
Intervention groups
patients with mild to moderate acne vulgaris, receive clindamycin 1% plus Cedar topical solution in the intervention group, and the topical solution of clindamycin 1% plus placebo in the control group randomly.
Main outcome variables
Comodon; postule and papule number
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171112037409N1
Registration date:2018-05-04, 1397/02/14
Registration timing:registered_while_recruiting
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Rasoul Shakiba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9724
Email address
shakiba.r@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-04, 1397/02/14
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of Ziziphus spina-christi topical solution plus clindamycin 1% compared with Clindamycin1% plus placebo in mild to moderate acne
Public title
Effect of topical Cedar on Acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects in age of 15 to 45 years old
Chief complaint: mild to moderate Acne vulgaris
subject willingness of herbal topical medicines use
Exclusion criteria:
pregnancy
lactation
History of polycyctic ovary
use of acnegenic medications such as corticosteroid, hurmonal or anti-psychotic medications
mechanical acne and gram-negative folliculitis
History of dermal allergy
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and investigator will be blinded to the treatment allocation throughout the course 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 Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9221309202
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
at the beginning of the study, 2nd, 6th and 8th weeks.
Method of measurement
counting the comedones, papules and pustules
2
Description
Severity of Acne
Timepoint
at the beginning of the study, 2nd, 6th and 8th weeks.
Method of measurement
Acne Severity Index
Secondary outcomes
1
Description
adverse effects including redness, burning and itching
Timepoint
2nd, 6th and 8th weeks of study.
Method of measurement
observation and physical examination
Intervention groups
1
Description
Intervention group: The topical solution of clindamycin (1%), with topical cedar solution, is applied 2 times a day for 6 weeks on the face.
Category
Treatment - Drugs
2
Description
Control group: The topical solution of 1% Clindamycin plus placebo is applied 2 times a day for 6 weeks on face.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Behesht clinical and Educational centre
Full name of responsible person
Rasoul Shakiba
Street address
No 487, Behesht St, vahdat Islami St
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9723
Fax
Email
rasoul.shakiba@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Ali Javad Mosavi
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Rasoul Shakiba
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 487 Behesht St . Vahdadt Islami St
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 215569321
Email
rasoul.shakiba@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Roshanak Ghods
Position
Assistant Professor of Iranian Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 487 Behesht St . Vahdadt Islami St
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9723
Email
roshanakghods@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rasoul Shakiba
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 487 Behesht St . Vahdadt Islami St
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 215569321
Email
rasoul.shakiba@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