Comparison of the effectiveness of doxycycline capsules with and without curcumin capsules in the treatment of patients with acne vulgaris
Design
A controlled clinical trial with a parallel group design on 200 patients. Patient allocation will be done using a random draw method.
Settings and conduct
Location of this study: Dermatology Clinic, Razi Hospital, Ilam City, Study population: Patients with acne vulgaris, Blinding is not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Moderate to severe acne vulgaris and consent to participate in the study.
Exclusion criteria: Prescription of topical or systemic medications that could potentially interfere with our treatment course, anti-acne treatment in the past two weeks, symptoms of hyperandrogenism, irregular menstrual cycles, acne fulminans, acne conglobata, liver dysfunction.
Intervention groups
The intervention group initially received medications containing 100 mg of doxycycline and labeled A, while the control group received 100 mg of doxycycline + 500 mg of curcumin in a capsule shell and labeled B.
Main outcome variables
Facial inflammatory lesions
GAGS Global Acne Severity Scoring System
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250412065291N2
Registration date:2025-09-29, 1404/07/07
Registration timing:retrospective
Last update:2025-09-29, 1404/07/07
Update count:0
Registration date
2025-09-29, 1404/07/07
Registrant information
Name
elham shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 3721
Email address
eshafiei1524@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-25, 1403/03/05
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of doxycycline capsules with and without curcumin capsules in the treatment of patients with acne vulgaris
Public title
Studying the effect of curcumin on acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having moderate to severe acne vulgaris
consenting to participate in the study
Exclusion criteria:
Prescription of topical or systemic medications that could potentially interfere with our treatment course
Anti-acne treatment in the past two weeks
Symptoms of hyperandrogenism
Irregular menstrual cycles
Acne fulminans
Acne conglobata
Liver dysfunction
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation through drawing a piece of paper from a bag: First, 100 letters A and 100 letters B are written on special papers that contents are not visible. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is taken out randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by drawing a card.
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 Ilam University of Medical Sciences
Street address
Banganjab-Ilam university of medical science
City
Ilam
Province
Ilam
Postal code
6931854919
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.MEDILAM.REC.1402.289
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
Area of acne scars
Timepoint
Measurement of inflammatory lesions 3 months after intervention
Method of measurement
Measuring with a ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in Group A will receive 100 mg of doxycycline. The medication will be prescribed for 12 weeks, with participants taking one capsule daily in the morning on an empty stomach.
Category
Treatment - Drugs
2
Description
Control group: Patients in group B will receive a capsule containing 100 mg of doxycycline and 500 mg of curcumin. The medication will be prescribed for 12 weeks, with participants taking one capsule daily in the morning on an empty stomach.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam KHomeini hospital
Full name of responsible person
Shokofeh Sharifi
Street address
Ilam University of Medical Sciences, Banganjab
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 3721
Email
sharifi-s@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr.Shokofeh Sharifi
Street address
Ilam University of Medical Sciences, Banganjab
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 3721
Fax
Email
sharifi-s@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Shokofeh Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Ilam University of Medical Sciences, Banganjab
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 3721
Email
sharifi-s@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shokofeh Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Ilam University of Medical Sciences, Banganjab
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 3721
Email
sharifi-s@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shokofeh Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Ilam University of Medical Sciences, Banganjab
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 3721
Email
sharifi-s@medilam.ac.ir
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