This controlled clinical trial will recruit 100 male and female patients (age: 12 to 30 years old) with mild to moderate acne (without clindamycin sensitivity) who visit the dermatology clinic of Afzalipour Hospital (Kerman,Iran).Table of random numbers will be used for random allocation of the patients. Intervention group will have to apply 1% niosomal clindamycin phosphate solution twice daily. Control group will have to apply 1% clindamycin phosphate solution twice daily.
Acne severity with lesions count and type(Inflammatory and Non-inflammatory) and acne grading with Global Acne Grading System(GAGS) will be evaluated at baseline. response of treatment will be evaluated by measurement of acne severityand grading with GAGS at week 2, 4, 8, 12. Finally Changes will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080635524N1
Registration date:2017-10-19, 1396/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Hoda Badakhsh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3322 2250
Email address
m_khalili@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor researsh,Kerman University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing thr efficacy of topical 1 % clindamycin phosphate and niosomal clindamycin phosphate 1% solusion in reduction of acne vulgaris lesions
Public title
Effectiveness of niosomal clindamycin solution in treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mild to moderate acne vulgaris; Both male and female;age (12-30years); lack of treatment during the one month period before the study
exclusion criteria: pregnancy; breast feeding; hypersensitivity to clindamycin; history of inflamatory bowel disease(IBD); history of neuromuscular junction blocker using; history of systemic retinoid using in the past 6 month; history of oral estrogen using in the past 3 month; history of topical retinoid and oral antibiotic using in the past 1 month; history of antimicrobial soap and comedogenic products using in the past 2 weeks; history of astringents and abrasive products using in the past 1 week; hirsutism; androgenetic alopecia; Polycystic ovarian syndrome.
Age
From 12 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Pardis of Kerman University of Medical Sciences, beginning of Haftbgh Alavi Highway, Kerman
City
Kerman
Postal code
7616913555
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
K/93/535
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
Acne severity
Timepoint
Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention
Method of measurement
Inflammatory and non-inflammatory lesions count, mild acne: most non-inflammatory lesions or less than 15 inflammatory lesions, moderate acne: 15 to 50 inflamatory lesions
2
Description
Acne grading
Timepoint
Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention
Method of measurement
Global Acne Grading system: The face is divided into five parts, forehead(2 factor), right and left cheek(2 factor), nose(1 factor), chin(1 factor), no lesions = 0, comedones = 1, papules = 2, pustules = 3 and nodules = 4. The score for each area (Local score) is calculated using the formula: Local score = Factor × Grade (0-4). The global score is the sum of local scores.
Secondary outcomes
1
Description
Erythema
Timepoint
Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention
Method of measurement
Inspection
2
Description
Pruritus
Timepoint
Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention
Method of measurement
Questionnaire
3
Description
Scaling
Timepoint
Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention