This study was designed to determine the effect of topical 5% N-acetylcysteine gel compared to placebo on the treatment and quality of life of patients with mild to moderate acne vulgaris.
Design
This study will be conducted as a randomized, double-blind, phase 3, parallel-group clinical trial involving 146 patients with mild to moderate acne vulgaris referred to Farschian Hospital in Hamadan. Patients will be divided into two groups and will be treated for 8 weeks. The rand function of Excel software was used for randomization.
Settings and conduct
The study will be conducted at Farshchian Hospital (Skin department) in Hamadan on patients with mild to moderate acne vulgaris to determine the effect of topical 5% L-N-acetylcysteine on acne. The study is double-blind. The patient and the person assessing the outcome of the treatment will be unaware of the groups.
Participants/Inclusion and exclusion criteria
Participants were patients with mild to moderate acne vulgaris on the face. Inclusion criteria were age 12 to 30 years, number of inflammatory and non-inflammatory lesions between 20 and 100, and no use of topical or oral acne treatments in the past 3 months. Exclusion criteria included: having underlying medical conditions such as diabetes or thyroid disorders, being pregnant or breastfeeding, having a history of refractory acne, and having other types of acne (such as acne conglobata).
Intervention groups
One group of patients will receive topical N-acetylcysteine 5% gel plus topical clindamycin for 8 weeks. The other group will receive topical clindamycin plus placebo (base gel without N-acetylcysteine).
Main outcome variables
Study outcomes included change in acne lesion count based on the Global Acne Grading System (GAGS) index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N48
Registration date:2025-10-07, 1404/07/15
Registration timing:prospective
Last update:2025-10-07, 1404/07/15
Update count:0
Registration date
2025-10-07, 1404/07/15
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of topical N Acetylcystein%5 on mild to moderate Acne Vulgaris: a double blind randomized clinical trial
Public title
Acne Treatment with N-Acetylcysteine Gel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate facial acne vulgaris
Age 12–30 years
Lesion count: 20–100 inflammatory/non-inflammatory lesions
No systemic or topical acne treatments in the past 3 months
Exclusion criteria:
Pregnancy or lactation
History of treatment-resistant acne.
Other acne subtypes (e.g., conglobata)
Having underlying medical conditions such as diabetes or thyroid disorders
Age
From 12 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
The treatment allocation to the treatment and placebo groups will be done randomly. Using the method of four-way random blocks, patients will be divided into two groups: treatment and placebo. In this way, all the cases where, for example, two treatments A and B can be placed in four-way blocks will be considered and in the next step, the blocks will be selected using the table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
All gel tubes (both drug and placebo) are prepared in completely identical packaging without any recognizable identifiers by the Hamadan Faculty of Pharmacy. Each tube is coded A or B with no direct reference to the contents (NAC or placebo). A random assignment list is prepared by an independent person (skin assistant). This list is a confidential document that is disclosed at the end of the relevant code design. Therefore, the treating physician and the patient will be unaware of the contents inside the tubes (double-blind) and the relevant codes will be disclosed during the data analysis design.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2025-09-06, 1404/06/15
Ethics committee reference number
IR.UMSHA.REC.1404.454
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
Changes in acne severity
Timepoint
Before treatment, end of week 3, 6, and 8 after treatment
Method of measurement
Global Acne Grading System (GAGS)
Secondary outcomes
1
Description
Treatment complications
Timepoint
From the start of treatment to the end of the eighth week
Method of measurement
Questioning the patient
Intervention groups
1
Description
Intervention group: will be treated with topical 5% N-acetylcysteine gel and topical clindamycin.
Category
Treatment - Drugs
2
Description
Control group: They will receive placebo (base gel without N-acetylcysteine) along with topical clindamycin
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshcian Hospital (Sina)
Full name of responsible person
Bahareh Ebrahimi
Street address
Mirzadeh Eshghi
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3264 0030
Email
Sina@Umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838697
Phone
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Bahareh Ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Mirzadeh Eshghi
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3264 0030
Email
b.ebrahimi.4362@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From 2026 onwards it is permissible
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
For treatment of patients and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
b.ebrahimi.4362@gmail.com
What processes are involved for a request to access data/document