Protocol summary

Study aim
The overall goal of this project was to find out the effect of chamomile flower extract on inflammatory acne vulgaris formulated in gel formulation to determine the rate at which it can cure or prevent acne.
Design
In this randomized clinical trial study, 44 patients with mild to moderate acne vulgaris who were included in the study were divided into two parallel control groups (group 1: clindamycin gel 1%) and intervention group (group 2: clindamycin gel combination 1% and Topical chamomile gel (2%), in which each group consisted of 22 individuals, was studied.
Settings and conduct
After preparing the whole chamomile extract and formulating it as a gel, the design was carried out at a dermatologist's clinic in Sina Hospital under the supervision of a specialist physician. Patients were informed of their satisfaction with the explanations given in this regard. They completed the questionnaire. Patients participating in the study were evaluated weekly and their information was recorded in the relevant questionnaire.
Participants/Inclusion and exclusion criteria
In this randomized clinical trial study, 44 patients with mild to moderate acne vulgaris who had inclusion criteria Entry requirements: Patients with mild to moderate acne Patients who have at least 2 inflammatory lesions (papules and pustules). • Not having any skin diseases involved, such as allergic, etc. • Patients who do not need systemic antibiotics. Exclusion criteria: Patients with severe acne • Having other skin diseases that affect the study • Patient dissatisfaction • In case of drug allergy
Intervention groups
The effect of formulated gel of chamomile extract on acne vulgaris in two groups is as follows: Control group (group 1: clindamycin gel 1%) Intervention group (Group 2: clindamycin gel 1% and chamomile gel 2%)
Main outcome variables
Number of Papules; Number of Postures; Number of Comedones

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190526043718N1
Registration date: 2019-08-29, 1398/06/07
Registration timing: retrospective

Last update: 2019-08-29, 1398/06/07
Update count: 0
Registration date
2019-08-29, 1398/06/07
Registrant information
Name
Mahsa Dolatpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 2250
Email address
mahsa.d.panah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-04-17, 1398/01/28
Actual recruitment start date
2018-11-02, 1397/08/11
Actual recruitment end date
2019-04-25, 1398/02/05
Trial completion date
2019-04-25, 1398/02/05
Scientific title
Effect of Chamomile Extract Gel on Acne Vulgaris Recovery in Patients Referred to Dermatology Department of Sina Hospital in Tabriz and Comparison with Clindamycin gel
Public title
Effect of chamomile gel on acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with mild to moderate acne All patients with acne who do not need systemic medication
Exclusion criteria:
People who are allergic to herbal ingredients Those with severe acne People who need antibiotics or other medications
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 44
Actual sample size reached: 44
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
No. 3, Mokhaberat َAlley,Fifth Alley,Shahid Chamran Square
City
Sarab
Province
East Azarbaijan
Postal code
5471954833
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR.TBZMED.REC.1397.526

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
The mean number of papules, pustules and comedones and the total number of inflammatory lesions and comparing them in control and intervention groups
Timepoint
Measurement of Papules, Pustules and Commons at baseline (before intervention) and 21, 14, 7 days after drug administration in both groups
Method of measurement
View and count the number of acne

Secondary outcomes

1

Description
Percentage of complete recovery after treatment in both groups
Timepoint
7،14،21 days after intervention (baseline)
Method of measurement
Observe and measure the number of acne

Intervention groups

1

Description
Intervention group: 22 patients treated with gel of chamomile plant extract 2%(twice daily) for 21 days were treated topically on the lesion only.
Category
Treatment - Drugs

2

Description
Control group: 22 patients treated with topical clindamycin gel 1% (once daily) for 21 days were treated with topical only on the lesion.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospita
Full name of responsible person
Hamide Azimi
Street address
Sina Hospital, Azadi Ave., between Shahid Montazeri and Hafez intersection, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5471954833
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Faculty of Pharmacy, Attar Neyshaburi Street, Neyayesh Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 4798
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, 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
Yousef Javadzade
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Attar Neyshaburi Street, Neyayesh Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Email
javadzadehy@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Yousef Javadzade
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Attar Neyshaburi Street, Neyayesh Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Email
javadzadehy@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Yousef Javadzade
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Attar Neyshaburi Street, Neyayesh Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Email
javadzadehy@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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