Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left triple-blind comparative clinial trial
This clinical trial aims to compare the effects of black seed cream with tretinoin cream in acne vulgaris
Design
This study is a triple-blind randomized clinical trial.
Settings and conduct
This clinical trial will be conducted in Dr Ali Shariati hospital Alborz university of medical science and Razi hospital Tehran university of medical science. Participants, healthcare providers ,and statistics specialist will be all blinded.
Participants/Inclusion and exclusion criteria
Individuals aged between 18-50 years old (regardless of gender) diagnosed with mild to moderate facial acne vulgaris (GAGS score ranging from 1 to 30) , and discontinued any topical or systemic treatments for acne at least 3 months prior to the intervention are included in this study. Exclusion criteria are as following: women with hirsutism or hormonal problems, pregnancy, breastfeeding, sensitivity to tretinoin or balck seed, and candidates for isotretinoin treatment.
Intervention groups
The number of 40 patients participating in this study are considered as 80 half faces, and are allocated into 2 equal groups receiving either tretinoin 0.05% or black seed creams for 12 weeks.In the three-month follow-up period, the patients will use identical facial cleansers and sunscreens.
Main outcome variables
The main outcome variables are acne lesion counts, reduction of GAGS score ,and the adverse reactions of the intervention medications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191021045173N1
Registration date:2020-04-03, 1399/01/15
Registration timing:prospective
Last update:2020-04-03, 1399/01/15
Update count:1
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Sarvenaz Zandkarimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 0051
Email address
sarvenazkarimi96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left triple-blind comparative clinial trial
Public title
Black seed vs. Tretinoin in acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-50 years regardless of gender
Clinical diagnosis of mild to moderate facial acne (GAGS score ranging from 1 to 30) made by a dermatologist
Discontinuation of any topical or systemic treatment for acne from at least 3 months prior to participation
Exclusion criteria:
Pregnancy or lactation,
Women with hirsutism, menstrual disorders and hormonal problems,
Severe grade of acne,
Candidate for isotretinoin treatment,
Known allergy to black seed or tretinoin,
Subjects who are non-cooperative or unsatisfied with the treatment
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
One half of the face will receive Tretinoin cream while in the other half, Black seed cream will be applied.
Randomization (investigator's opinion)
Randomized
Randomization description
The 40 patients are considered as 80 half faces and are allocated into two comparison groups. Simple randomization procedure, dice rolling, with a 1 : 1 allocation ratio will be performed as fallowing: for the right half face, the odd numbers are to receive black seed cream, and the even numbers tretinoin 0.05%. The left half of the face is to receive the reverse medication so as to make comparison of 2 medications in the same subject.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The allocation sequence will be only known to a person who is not involved in study process; the patients, healthcare providers,and statistical specialist are all blinded.The aforementioned person will label identical sealed aluminum tubes of black seed 20% and tretinoin 0.05% in cream forms as either “left” or “right” for each participant half face according to the allocation sequence.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Medical Sciences
Street address
Faculty of pharmacy, Islamic Azad University of Medical Sciences, Yasaman Alley, Yakhchal Street, District 1, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.IAU.TMU.REC.1398.171
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
Acne lesion counts
Timepoint
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly clinical examination in a three-month follow-up period by 2 dermatologists
Method of measurement
Independent assessment of lesion counts: comedones, papules/pustules
2
Description
Reduction of Global Acne Grading System (GAGS) score
Timepoint
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly clinical examination in a three-month follow-up period by 2 dermatologists
Method of measurement
Rating of acne according to Global Acne Grading System (GAGS) by two dermatologists
3
Description
Patients satisfaction
Timepoint
Baseline (before intervention) and 4, 8, 12 weeks after intervention with the addition of monthly visits in a three-month follow-up period
Method of measurement
Patient subjective satisfaction score ranging from 1 to 100
4
Description
Adverse reactions of the study medications
Timepoint
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly visits in a three-month follow-up period
Method of measurement
Patients reports and clinical assessments by two dermatologists
5
Description
Photographic assessment
Timepoint
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly assessments in a three-month follow-up period by 2 dermatologists
Method of measurement
Digital camera
Secondary outcomes
empty
Intervention groups
1
Description
40 patients are considered as 80 half faces ,and 2 comparison groups are designed as 40 right and 40 left half faces in order to omit the interindividual differences and compare each participant responses to the medications with her/himself. Patients will be individually instructed to apply a thin layer of the given topical medications which are labelled as "left" and "right" on the determined side of the clean facial skin for 12 weeks as twice daily administration. In the three-month follow-up period, the patients will use identical facial cleansers and sunscreens.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Ali Shariati hospital
Full name of responsible person
Dr. Zahra Azizian
Street address
Dr Shariati hopital, Mahdasht, Karaj, Alborz, Iran
City
Karaj
Province
Alborz
Postal code
19419
Phone
+98 21 2264 0056
Email
azizian.z@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19419
Phone
+98 21 2260 9043
Email
sarvenazkarimi96@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19419
Phone
+98 21 2264 0056
Email
mehdirj@aol.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Zahra Azizian
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 2264 0056
Fax
Email
azizian.z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sarvenaz Zandkarimi
Position
Pharm. D.
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19419
Phone
+98 21 2264 0056
Email
sarvenazkarimi96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
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
Title and more details about the data/document
Only the data related to the measured outcomes will be published
When the data will become available and for how long
Availability starts after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
Applicants aught to send a request email containing their aims and how the data will be used to the given gmail address
From where data/document is obtainable
contact: Sarvenazkarimi96@gmail.com
What processes are involved for a request to access data/document
After assessment of the applicant's request, if agreed, the data files will be sent in the shortest possible time .