Evaluation of Spironolactone nano emulgel (1%) effect on skin characteristics and treatment of mild to moderate acne vulgaris in comparison with spironolactone gel 5%
The nano particles (SLN and NLC) of Spironolactonel will be prepared and the emulgel 1% will formulate by suitable polymer. The characteristics of nano particles (particle size, zeta potential and entrapment efficacy) will evaluate. The effect of spironolactone nano emulgel will be evaluated on acne in comparison with simple spironolactone gel 5%. The patients with mild to moderate acne will included in study. The samples which received any antibiotic in last 3 months will excluded from study. 30 patients will included in every group. The case group will recive Lavander nano emul-gel, and control group will receive tretinoin cream for 2 months.The skin lesions (comedone, papule and pustules in 0, 4, and 8m weeks) will be counted. The skin characteristics like sebum excretion, hydration, elasticity, redness and melanin content will define too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051010203N6
Registration date:2015-05-22, 1394/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-22, 1394/03/01
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
chancellor of research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-05-10, 1394/02/20
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Spironolactone nano emulgel (1%) effect on skin characteristics and treatment of mild to moderate acne vulgaris in comparison with spironolactone gel 5%
Public title
Effect of Spironolactone nano-emulgel 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, who were not satisfied with their previous acne therapies participated in the study after giving written informed consent
Exclusioncriteria: Patients were excluded if they had an uncontrolled systemic disease; had received topical antiacne therapy two months before or during the study or any systemic therapy with antibiotics, OCP, and spironolactone 30 days before or during the study; were known to be allergic or sensitive to any of the study medications or their components; had previously been treated with systemic retinoids; had a skin disease that might interfere with the diagnosis or evaluation of their hyperpigmentation; or were pregnant, or planning to become pregnant, and lactating.
Age
From 11 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Chancellor of Research, Mzandaran University of Medical Sciences
Street address
Moallem square
City
Sari
Postal code
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
91261
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
skin lesion
Timepoint
0, 4, and 8 weeks
Method of measurement
observation
Secondary outcomes
1
Description
sebum excretion
Timepoint
0, 4, 8 weeks
Method of measurement
sebometer
Intervention groups
1
Description
case: nano emulgel of spironolactone 1%, two times in day (BID) as topical, and for 2 months
Category
Treatment - Drugs
2
Description
control: spironolactone gel 5%. The preparations will be administered topically, two times in day and for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali Hospital
Full name of responsible person
Dr. Majid Saeedi
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moallem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Majid Saeedi
Position
Prof.
Other areas of specialty/work
Street address
18th. km. of khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of pharmacy
Full name of responsible person
Majid Saeedi
Position
Ph.D. in pharmaceutics
Other areas of specialty/work
Street address
18th. km. of khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Majid Saeedi
Position
Prof.
Other areas of specialty/work
Street address
18th. km of khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)