Protocol summary
-
Study aim
-
This clinical trial aims to compare the effects of black seed cream with tretinoin cream in acne vulgaris
-
Design
-
This study is a double-blind randomized clinical trial.
-
Settings and conduct
-
This clinical trial will be conducted in The Center for Research and Training in Skin Diseases and Leprosy, and Razi hospital of Tehran University of medical sciences. Participants and healthcare providers will be blind.
-
Participants/Inclusion and exclusion criteria
-
Inclusion 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); discontinued any topical or systemic treatments for acne at least 3 months prior to the intervention. Exclusion criteria: women with hirsutism or hormonal problems, pregnancy, breastfeeding, sensitivity to tretinoin or balck seed, and candidates for isotretinoin treatment.
-
Intervention groups
-
The number of 20 patients participating in this study are considered as 40 half faces, and are allocated into 2 equal groups receiving either tretinoin 0.05% or black seed creams for 8 weeks. Through the treatment period and in the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
-
Main outcome variables
-
Acne lesion counts; reduction of GAGS score; the adverse reactions of the intervention medications.
General information
-
Reason for update
-
Firstly, due to COVID pandemy, sample size and treatment duration were decreased, additionally, completing the study took longer time than expected. Secondly, in order to assess the acne lesions more detailedly, the study took place in The Center of Research and Training in Skin Diseases and Leprosy, in which its equipments (visiopore device, tewameter, corneometer, pHmeter, and mexameter probes) were employed.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20191021045173N1
Registration date:
2020-04-03, 1399/01/15
Registration timing:
prospective
Last update:
2022-02-09, 1400/11/20
Update count:
1
-
Registration date
-
2020-04-03, 1399/01/15
-
Registrant information
-
-
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
-
2020-11-01, 1399/08/11
-
Actual recruitment end date
-
2021-10-01, 1400/07/09
-
Trial completion date
-
2022-01-05, 1400/10/15
-
Scientific title
-
Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left double-blind comparative clinical trial
-
Public title
-
Black seed vs. Tretinoin in acne vulgaris
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age between 18-50 years
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
-
- Participant
- Care provider
- Investigator
- Outcome assessor
-
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.
Actual sample size reached:
20
More than 1 sample in each individual
Actual sample size in each individual:
2
One half of the face received tretinoin cream, and the other half, back seed cream
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Treatment tubes were randomly labeled by a third party not involved in the study from 1 to 40 so that the tubes with odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% cream. The 20 patients were considered as 40 half faces and were randomly allocated into two comparison groups. Simple randomization procedure with an 1 : 1 allocation ratio was performed as following: subjects with odd admission numbers were supposed as ‘right half-face: odd-numbered tube’ (group I) and the ones with even admission numbers were assumed as ‘left half-face: odd-numbered tube’ (group II). In each case, the reverse half-face was given an even-numbered tubes.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Treatment tubes were randomly labeled by a third party not involved in the study from 1 to 40 so that the tubes with odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% cream.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
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 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
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 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
Rating of acne according to Global Acne Grading System (GAGS) by two dermatologists
3
-
Description
-
Patients satisfaction
-
Timepoint
-
4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
Patient subjective satisfaction score ranging from 1 to 100
4
-
Description
-
Adverse reactions of the study medications
-
Timepoint
-
4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
Patients reports and clinical assessments by two dermatologists
5
-
Description
-
Photographic assessment
-
Timepoint
-
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
Digital camera
6
-
Description
-
Visiopore parameters (quantity, size, and value)
-
Timepoint
-
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
Visiopore device
7
-
Description
-
skin hydration
-
Timepoint
-
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
Corneometer probe
8
-
Description
-
skin erythema
-
Timepoint
-
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
mexameter probe
9
-
Description
-
skin melanin
-
Timepoint
-
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
mexameter probe
10
-
Description
-
Transepidermal water loss
-
Timepoint
-
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
Tewameter probe
11
-
Description
-
Skin pH
-
Timepoint
-
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
-
Method of measurement
-
pHmeter probe
Intervention groups
1
-
Description
-
20 patients are considered as 40 half faces ,and 2 comparison groups are designed as 20 right and 20 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 8 weeks as twice daily administration. Through the treatment period and the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
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
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 .
-
Comments
-