Determination of the effect of injectable pantothenic acid in the treatment of mild to moderate acne
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 60 patients. Random Allocation software is used for randomization
Settings and conduct
This study is conducted on patients with mild and moderate acne who refer to skin clinics of Shiraz University of Medical Sciences. Patients are randomly divided into two groups. Blinding is performed only at the level of the outcome assessor. The first group is treated with dexpanthenol 500 mg ampoule, one intramuscular injection, and adapalene gel per week. The second group will only be treated with adapalene gel topically every other night.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with mild to moderate acne, 2. Patients have not received any systemic treatment in the last month and have not received any local treatment in the last two weeks 3. Married women agreed to use physical methods of contraception such as condoms and IUDs during the study. Exclusion criteria: 1- pregnant and lactating women 2- patients with polycystic ovary syndrome 3- use of herbal medicines 4- lack of consent to continue the study 5- history of allergy to the study drug 6- allergy to adapalene gel 7- impossibility Regular visits to check the response to treatment 8- Patients with severe acne 9- Existence of systemic disease including kidney and liver problems 10- Current use of food supplements for skin health
Intervention groups
The first group is treated with dexpanthenol 500 mg ampoule manufactured by Actover pharmaceutical company, one intramuscular injection and adapalene gel per week. The second group will only be treated with adapalene gel topically every other night
Main outcome variables
Severity of acne using GAGS (Global Acne Grading System)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N19
Registration date:2023-11-04, 1402/08/13
Registration timing:prospective
Last update:2023-11-04, 1402/08/13
Update count:0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of intramuscular injection of pantothinic acid in patients with mild to moderate acne referred to dermatology clinics
Public title
Evaluation of efficacy of intramuscular injection of pantothinic acid in patients with mild to moderate acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate acne
Patients have not received any systemic treatment in the last one month and have not received any local treatment in the last two weeks
Married women who agree to use physical methods of contraception such as condoms and IUDs during the study
Exclusion criteria:
Pregnant and lactating women
Patients with polycystic ovary syndrome
Lack of consent to continue studying
Use of herbal medicines
History of allergy to the studied drug
Allergy to adapalene gel
Inability to visit regularly to check response to treatment
Patients with severe acne
Existence of systemic disease including kidney and liver problems
Current use of dietary supplements for skin health
Age
From 16 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By using random allocation software, consecutive permutation blocks with the size of 6 people in each block are made and the patients are divided into two groups A (first treatment method) and B (second treatment method).
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the clear difference in the treatment method and the different drug form in each study group, blinding is done only at the level of the outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
In this plan, placebo is not used and each group will be prescribed a different medicine with the purpose of treatment
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical School of Shiraz University of Medical Sciences
Street address
Medical School of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.SUMS.MED.REC.1402.208
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Acne severity
Timepoint
Base line, first month, second month
Method of measurement
Acne severity GAGS (Global Acne Grading System)
Secondary outcomes
1
Description
Quality of life of the patients
Timepoint
Base line, first month, second month
Method of measurement
Dermatology Quality of Life Index
2
Description
Acne count
Timepoint
Base line, first month, second month
Method of measurement
Counting the acne lesions
Intervention groups
1
Description
Intervention group: The first group is treated with dexpanthenol 500 mg ampoule manufactured by Actover pharmaceutical company, one intramuscular injection and adapalene gel per week.
Category
Treatment - Drugs
2
Description
Control group: The second group will only be treated with adapalene gel topically every other night
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Dermatology Clinic
Full name of responsible person
Dr. Nasrin Saki
Street address
Emam Reza Poly Clinic, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
nasrinsa85@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Faghihi Dermatology Clinic
Full name of responsible person
Dr. Nasrin Saki
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348466114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur, MD
Street address
7th floor,Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
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
Fahimeh Mohammadi, MD
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Zand Avenue, Shahid Faghihi Hospital
City
Fars
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
fahimeh.mohammadi8606@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Saki, MD
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand Avenue, Shahid Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
nasrinsa85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Parvizi, MD
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
mmparvizi@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
One year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document