Comparing efficacy of combination therapy with niosomal benzoyl peroxide 1% - clindamycin 1% versus niosomal Clindamycin1% in acne vulgaris: A randomized clinical trial
Comparing efficacy of combination therapy with niosomal benzoyl peroxide 1% - clindamycin 1% versus niosomal Clindamycin1% in acne vulgaris: A randomized clinical trial
Design
The study is a double-blind,randomized clinical trial with control group and parallel group design
Settings and conduct
This is a randomized double-blind clinical trial study. One hundered patients with mild to moderate acne vulgaris between 12 to 30 years old, attending Afzalipour hospital in Kerman enrolled the study. Patients were allocated to 2 groups (intervention and control) . Intervention group will receive combination of niosomal clindamycin (CL) 1% and benzoil peroxide (BPO) 1% and the control group will receive niosomal clindamycin 1%.
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients with age between 12 to 30 years old. Exclusion criteria were pregnancy; lactation; history of allergy to clindamycin or BPO; previous history of inflammatory bowel disease ; colitis due to antibiotics; taking neuromuscular blockers and oral anti -acne drug since 6 months ago ; topical anti-acne drugs since 1 month ago;polycystic ovary syndrome; hirsutism
Intervention groups
Patients in case group were received niosomal combination of BPO 1% /CL1%(twice daily for 12 weeks) and in control group niosomal CL1%(twice daily for 12 weeks), respectively.
Main outcome variables
Number of lesions; severity of acne lesions ; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035524N5
Registration date:2018-08-15, 1397/05/24
Registration timing:registered_while_recruiting
Last update:2018-08-15, 1397/05/24
Update count:0
Registration date
2018-08-15, 1397/05/24
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
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy of combination therapy with niosomal benzoyl peroxide 1% - clindamycin 1% versus niosomal Clindamycin1% in acne vulgaris: A randomized clinical trial
Public title
Evaluating efficacy of combination therapy with niosomal benzoyl peroxide and clindamycin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with age between 12 to 30 years old.
patients with mild to moderate acne vulgaris
Exclusion criteria:
pregnancy
lactation
history of allergy to clindamycin or BPO
previous history of inflammatory bowel disease,colitis
polycystic ovary syndrome,
hirsutism,
taking neuromuscular blockers or oral anti -acne drug since 6 months ago
topical anti-acne drugs since 1 month ago
Age
From 12 years old to 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was done using Minitab 16 software (Mini Tab Inc.)
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a triple-blind study for outcome assessor,patients and analyzor.
Both drugs were kept in identical amber glass containers,so the evaluating physician and patients were unaware of the content of the containers.
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
Ebne Sina Ave.,Tahmasb Abad Blvd.
City
Kerman
Province
Kerman
Postal code
761614111
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.KMU.REC.1395.116
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 lesion severity
Timepoint
At base line and 2,4, 8 and 12 weeks later
Method of measurement
Counting of acne lesions by physical examination, GAGS(Global Acne Grading System)
2
Description
Number of counting of inflammatory and non-inflammatory acne lesions
Timepoint
At base line and 2,4, 8 and 12 weeks later
Method of measurement
counting of acne lesions by physical examination
3
Description
Quality of life
Timepoint
At base line and 2,4, 8 and 12 weeks later
Method of measurement
by Cardiff Acne Disability Index (CADI) questionnair
Secondary outcomes
1
Description
Erythema
Timepoint
at base-line(before intervention) and at weeks 2, 4, 8,12
Method of measurement
by physical examinatin
2
Description
Scaling
Timepoint
at base-line(before intervention) and at weeks 2, 4, 8,12
Method of measurement
by physical examination and classification of the severity of adverse effects to mild, moderate and severe.
3
Description
pruritis
Timepoint
at base-line(before intervention) and at weeks 2, 4, 8,12
Method of measurement
by physical examination and classification of the severity of adverse effects to mild, moderate and severe.
Intervention groups
1
Description
Intervention group: niosomal combination of BPO 1% and CL 1% lotion. Route of administration: topical application, twice a day; duration of treatment: 12 weeks; manufacturing factory: Sorbitan monostearate (Span 60), polysorbate 60 (Tween 60) and cholesterol were purchased from Fluka, Switzerland. All other chemicals and soluble materials were prepared by Merck company, Germany.
Category
Treatment - Drugs
2
Description
Control group: niosomal CL1% lotion,Route of administration:topical aplication,twice daily,duration of treatment: for 12 weeks, manufacturing factory: Sorbitan monostearate (Span 60), polysorbate 60 (Tween 60) and cholesterol were purchased from Fluka, Switzerland. All other chemicals and soluble materials were prepared by Merck company, Germany
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Mahin Aflatoonian
Street address
Imam high way,Kerman
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Ebne sina Avenue, Jehad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mahin Aflatoonian
Position
assistant professor of dermatology
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital, Imam high way
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahin Aflatoonian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital, Imam high way
City
Kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahin Aflatoonian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital, Imam high way
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available