Comparison of the efficacy of brimonidine 0.33% gel and placebo in the treatment of post-acne erythema
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 30 patients, double blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the dermatology clinic of Shiraz University of Medical Sciences. Group 1 will apply Brimonidine 0.33% gel once overnight on the face. Group two will apply Lubricant gel once overnight on the face. The patients are assessed at the beginning of treatment, 4th week, and 8th week of treatment and one month after cessation of treatment Visioface photography. The patients and outcome assessor are blinded to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between 18 and 45 years of age with post-acne erythema after successful treatment of acne vulgaris
Exclusion criteria: pregnancy, lactation, depression, cerebral or coronary artery insufficiency, severe or unstable cardiovascular disease
Intervention groups
Intervention group: Brimonidine 0.33% gel (Janus, Tehran, Iran) is applied once overnight on the face.
Control group: Lubricant gel (Razak, Tehran, Iran) is applied once overnight on the face.
Main outcome variables
Clinician score of post-acne erythema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140212016557N11
Registration date:2023-07-31, 1402/05/09
Registration timing:prospective
Last update:2023-07-31, 1402/05/09
Update count:0
Registration date
2023-07-31, 1402/05/09
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Brimonidine 0.33% gel and placebo on the clinical erythema score in post-acne erythema patients
Public title
Assessing the effect of brimonidine gel on the redness remained after pimples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 45 years of age
Post-acne erythema after successful treatment of acne vulgaris
Exclusion criteria:
pregnancy
lactation
depression
cerebral or coronary artery insufficiency
Raynaud’s phenomenon
orthostatic hypotension
thromboangiitis obliterans
scleroderma
Sjögren’s syndrome
severe or unstable cardiovascular disease
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are recruited by consecutive sampling in the study. Randomization is performed by random allocation software and participants are randomly allocated in the intervention or control group. Randomization of 30 participants in the software is performed by randomization blocks size 4 with random ratio of 1:1. The output of the software is a table that shows the number of each participant is allocated in the intervention or control group. The medications are in the similar containers labeled by numbers of the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drugs are packed in similar containers and have similar color, smell, and texture; and, the containers allocated to each patient are labelled with the same patients of patient recruitment number. Care provider and investigator that deliver the gels are not involved in the outcome assessment. The outcome assessor is not aware of the type of drugs in each patient. Due to similarity of the drugs and the instructions, the patients are also unaware of the type of used drugs. Therefore the research will be double-blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of MedicalSscience, zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.SUMS.MED.REC.1402.052
Health conditions studied
1
Description of health condition studied
Post-acne erythema
ICD-10 code
L70.8
ICD-10 code description
Other acne
Primary outcomes
1
Description
Clinician score of post-acne erythema
Timepoint
Before intervention, 4 and 8 weeks after starting intervention, and 1 months after treatment cessation
Method of measurement
5-point clinical score, defined as: 0=clear with no erythema, 1 = almost clear or slight redness, 2 = mild or definite redness, 3 = moderate or marked redness, 4 = severe or fiery redness
Secondary outcomes
1
Description
Skin erythema index
Timepoint
Before intervention, 4 and 8 weeks after starting intervention, and 1 months after treatment cessation
Method of measurement
Dermacatch instrument
2
Description
Patient self-assessment of post acne erythema treatment
Timepoint
4 and 8 weeks after starting intervention, and 1 months after treatment cessation
Method of measurement
4-point patient assessment of treatment result expressedas: a. No improvement, b. Mild improvement, c. Good improvement, d. Excellent improvement
3
Description
Quality of life
Timepoint
before intervention and 1 months after cessation of treatment
Method of measurement
Dermatology Life Quality index questionnaire Persian version
Intervention groups
1
Description
Intervention group: Brimonidine 0.33% gel (Janus, Tehran, Iran) is applied once overnight on the face.
Category
Treatment - Drugs
2
Description
Control group: Lubricant gel (Razak, Tehran, Iran) is applied once overnight on the face.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Mozhdeh Sepaskhah
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Email
sepaskhah@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Research Council, Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Research grant of the Research Council of Shiraz University of Medical Sciences
Grant code / Reference number
25880
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate prefessor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available