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Comparison of the effect of 0.1% tacrolimus ointment with 0.5% timolol solution in the treatment of Post Acne erythema

Protocol summary

Study aim
The main aim of the study is to compare the effect of 0.1% tacrolimus ointment with 0.5% timolol solution in the treatment of post-acne erythema.
Design
A controlled, parallel-group, single-blind, randomized phase 3 clinical trial will be conducted on 86 patients with post-acne erythema. The drawing card method will be used for randomization.
Settings and conduct
The study will be performed at the Farshchian (Sina) hospital, Hamadan City, on patients with post-acne erythema. Patients will be randomly assigned to two treatment groups: 0.1% tacrolimus topical ointment and 0.5% timolol maleate solution. The severity of erythema with a photo image of the lesion site based on the criteria of clinical evaluation of erythema, before treatment, at the end of the 4th 8th week of treatment, will be checked and compared. Groups with codes A and B will be sent to the analyst and after analyzing the results, the codes will be revealed (ُsingle blind).
Participants/Inclusion and exclusion criteria
Patients with acne vulgaris, over 18 years of age and declaration of consent to participate in the study. Conditions for not entering the study: history of using anti-acne drugs within 3 months before the treatment process, history of allergy to tacrolimus and timolol, prenancy and breastfeeding, bronchial asthma, severe COPD, sinus bradycardia, 2nd and 3rd degree heart block and heart failure
Intervention groups
One group of patients will be treated with 0.1% tacrolimus topical ointment and the other group will be treated with 0.5% timolol maleate eye solution. Both groups will use the drug once a night for 8 weeks
Main outcome variables
The severity of erythema; side effects of treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N33
Registration date: 2023-10-27, 1402/08/05
Registration timing: prospective

Last update: 2023-10-27, 1402/08/05
Update count: 0
Registration date
2023-10-27, 1402/08/05
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
2023-11-22, 1402/09/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 0.1% tacrolimus ointment with 0.5% timolol solution in the treatment of Post Acne erythema
Public title
The effect of tacrolimus ointment and timolol solution in the treatment of post-acne erythema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years Consent to participate in the study
Exclusion criteria:
History of allergy to tacrolimus and timolol History of using anti-acne drugs within 3 months before the treatment process Pregnant and lactating mothers bronchial asthma, severe COPD, sinus bradycardia, 2nd and 3rd degree heart block and heart failure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
We made 86 cards and write letter TA on 43 for tacrolimus and on the other 43 letter TI for the timolol group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter ( TA or TA) patients will be assigned to tacrolimus or timolol group
Blinding (investigator's opinion)
Single blinded
Blinding description
The person analyzing the data will analyze the groups as A and B and will be blind of the type of prescription drugs. A and B codes will be disclosed after the statistical analysis is completed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Hamedan University of medical science
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Approval date
2023-10-19, 1402/07/27
Ethics committee reference number
IR.UMSHA.REC.1402.479

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
Erythema
Timepoint
Before treatment, at the end of week 4 and at the end of week 8 of treatment
Method of measurement
Take a picture of lesions and and compare based on Clinical Erythema Assessment scale by dermatologist

Secondary outcomes

1

Description
Side effects of itching, burning, scaling and redness
Timepoint
4th and 8th week of treatment
Method of measurement
Clinical examination and asking the patient about complications

Intervention groups

1

Description
Intervention group: Tacrolimus ointment 0.1% will be used topically once a night for 8 weeks.
Category
Treatment - Drugs

2

Description
Intervention group: 0.5% timolol maleate solution will be used topically once a night for a period of 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fashchian (Sina) Hospital
Full name of responsible person
Dr. Mohammad Jamshidi
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
Dr Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
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
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Community medicine department, Medical School, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammad Jamshidi
Position
Associated 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
jamshidim84@yahoo.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 Ave
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
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
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 2024 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
To develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document
Send and receive email
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