Evaluation of spironolactone nanostructured lipid carriers coated with chitosan and clindamycin solution co-treatment effect on severity of mild to moderate acne vulgaris
Determination of spironolactone lipid nanoparticles coated by chitosan on acne
Design
The eligible patients will divided in two groups randomly and will receive every preparation twice in day. The number and kind of skin lesions will evaluate during 8 weeks.
Settings and conduct
The acne grade will define based on lesion count. The patient will receive topical preparations during 8 weeks. The patients, prescriber and evaluator are blind. The patients will evaluate at zero time, 2, 4, and 8 weeks. All of the patients will receive topical antibiotic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with mild to moderate acne, defined as a score of 1 to 30 on the global acne grading system (GAGS) scale,
Patients which received topical anti-acne therapy two months before or during the study or any systemic therapy with antibiotics, OCP, retinoid, and spironolactone before or during the study, patients were excluded if they had other disease; pregnant, or planning to become pregnant women, lactating, and allergic or sensitive patients to preparation will not include to study.
Intervention groups
Intervention group will receive clindamycin solution 2% and topical preparation containing coated spironolactone nanoparticles.
Control group will receive clindamycin solution 2% and placebo.
Main outcome variables
Non-inflammatory lesions (comedones); Inflammatory lesions (papule and pustule)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120707010203N11
Registration date:2021-01-11, 1399/10/22
Registration timing:registered_while_recruiting
Last update:2021-01-11, 1399/10/22
Update count:0
Registration date
2021-01-11, 1399/10/22
Registrant information
Name
Majid Saeedi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3082
Email address
msaeedi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of spironolactone nanostructured lipid carriers coated with chitosan and clindamycin solution co-treatment effect on severity of mild to moderate acne vulgaris
Public title
Evaluation of spironolactone nanoparticles coated with chitosan topical preparation effect on acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate acne, defined as a score of 1 to 30 on the global acne grading system (GAGS) scale.
Patients which received no previous acne therapies participated in the study, or have not received any treatment before this study
Exclusion criteria:
Patients which received topical anti-acne therapy two months before or during the study or any systemic therapy with antibiotics, OCP, retinoid, and spironolactone before or during the study
Patients were excluded if they had other disease;
Pregnant, or planning to become pregnant women
Lactating
Age
From 13 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control using simple randomization and patients will divide to intervention or placebo group based on their code. Randomization list will be done by online tool (https://www.random.org/lists) and sealed envelope will used for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
All of patients will received clindamycin 2% solution in two groups. The patients will receive topical preparation of spironolactone nanoparticles 1% in case group, and control group will receive placebo in similar packaging. Topical preparation and placebo have certain code and clinical evaluator has no information about them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology building, Moallem sq., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.MAZUMS.REC.1399.691
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
No. of lesions
Timepoint
At the beginning of study (time zero) and 2, 4 and 8 weeks after treatment
Method of measurement
clinical evaluation
Secondary outcomes
1
Description
Lesion kind (inflammatory or non-inflammatory)
Timepoint
At the beginning of study (time zero) and 2, 4 and 8 weeks after treatment
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: Topical preparation containing spironolactone nanoparticles (NLC) coated by chitosan (1%), will prepared as emulgel. The preparation will package and add code label , after physicochemical and microbial control. The patients will apply preparation twice in day for 8 months on skin lesions. They will receive clindamycin 2% solution as main treatment in this period of time too.
Category
Treatment - Drugs
2
Description
Control group: Topical placebo will prepared. The preparation will package and add code label , after physicochemical and microbial control. The patients will apply placebo twice in day for 8 months on skin lesions. They will receive clindamycin 2% solution as main treatment in this period of time too.