Protocol summary

Summary
The main goal of the current study is to determine the effect of licorice in treatment of acne in patients with acne vulgaris. The current study is a double-blinded clinical trial. The study was performed on 84 patients having acne vulgaris. Patients with acne vulgaris having comedone, papule, and pustule lesions on the face skin and age above 12 were included in the study. The exclusion criteria were age below 12, breastfeeding, pregnancy, and taking drugs such as oral and topical steroids and anticonvulsant drugs that are effective on development of acne. The patients were classified into two groups. One group received the routine treatment of oral doxycycline (200 mg/day) as one capsule every 12 hours plus 5% gel of total licorice extract applied to the face skin every other day, and the other group received oral doxycycline (200 mg/day) as one capsule every 12 hours plus placebo (gel vehicle) applied to the face skin once a day. One month after the treatment, the number of comedone, papule, and pustule lesions on the face skin were counted by the researcher and recorded in patients’ files. Finally, the data obtained for the two groups were analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122411864N1
Registration date: 2013-01-28, 1391/11/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-01-28, 1391/11/09
Registrant information
Name
Mahin Karimi
Name of organization / entity
Kurdistan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1613 1412
Email address
mohamadreza.rahmani@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Glycyrrhiza glabra gel on Acne in Acne –Vulgaris patients
Public title
The effect of Glycyrrhiza glabra gel on Acne in Acne –Vulgaris patients
Purpose
Treatment
Inclusion/Exclusion criteria
The major inclusion criteria: age above 12 years old; inflammatory acne of the face papule and/or pustules.The major exclusion criteria: should not have under 12 years; nor lactation; nor pregnancy; nor received Topical and oral steroid and Anticonvulsant drugs.
Age
From 12 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, opposite the hotel shadi, University Campus,Sanandaj
City
Sanandaj
Postal code
66177-13446
Approval date
2012-12-30, 1391/10/10
Ethics committee reference number
34088/14

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
Comodon, postule and papule number
Timepoint
Baseline and after the intervention period of 30 days
Method of measurement
Count

Secondary outcomes

1

Description
no
Timepoint
no
Method of measurement
no

Intervention groups

1

Description
Treatment groups: doxycycline and licorice gel 5%; Doxycycline 200 mg per day given. Taking the drug and gel once a day and Treatment for 1 month.
Category
Treatment - Drugs

2

Description
placebo groups: doxycycline and placebo ; Doxycycline 200 mg per day given. Taking the drug and gel once a day and Treatment for 1 month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic Bessat, Sanandaj
Full name of responsible person
Mohamadreza Rahmani
Street address
Farmer Street, besat Hospital ; Sanandaj
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi
Street address
Kurdistan University of Medical Sciences, opposite the Hotel Shadi, University Campus,Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mohamadreza Rahmani
Position
Ph.D of Immunology
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, opposite the Hotel Shadi, University Campus, Sanandaj
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 1613 1412
Fax
Email
mohamadreza.rahmani@muk.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mohamadreza Rahmani
Position
Ph.D of Immunology
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, opposite the Hotel Shadi, University Campus, Sanandaj
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 1613 1412
Fax
Email
mohamadreza.rahmani@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mahin Karimi
Position
Student Laboratory Science
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, opposite the Hotel Shadi, University Campus,Sanandaj
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 1613 1412
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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