Acne is a dermatological disorder that afflicts mainly young people. Even though acne is not a contagious and severe disease, but it is important due to its effects on patient's quality of life and social communications. Various topical treatments are used to treat acne. Benzoyl peroxide 5% is the commonly used treatment and due to its keratolytic and comedolytic properties can be used alone. In recent years, light-based therapies like intense pulsed light have drawn great attention. Because of its efficacy and multifactorial property of acne, the current trial aims to compare the effect of intense pulsed light and topical benzoyl peroxide to topical benzoyl peroxide alone. Total target sample size consists of 58 adult mile-to-moderate acne patients with inclusion criteria of receiving no antibiotic during past 2 weeks and no systemic steroid and retinoid during past 6 months, and no pregnancy. Exclusion criteria include irregular returns or being photosensitive. Control group receives topical benzoyl peroxide 5% for 3 months. Patients in treatment group receive IPL, in addition to topical treatment, 3 times with a month interval starting from the end of first month. The disease severity would be assessed by acne global severity scale and acne severity index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051727947N1
Registration date:2016-06-20, 1395/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-20, 1395/03/31
Registrant information
Name
Tohid Jafari Koshki
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 492 6048
Email address
tjkoshki@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-02-07, 1394/11/18
Expected recruitment end date
2016-06-12, 1395/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Benzoyl Proxide 5% and IPL and benzoyl Proxide 5%-alone in mild-to-moderate acne
Public title
Comparing the Effect of Benzoyl Proxide 5% and IPL andto Proxide 5%-alone in acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being afflicted with mild-to-moderate acne; patients who prefer to receive therapies faster than commonly used time-consuming treatments; having no acne scar; no pregnancy of breast feeding; consent to participate; receiving no antibiotic during past wo weeks or systemic steroid and retinoid during past 6 months; photosensitivity; no tendency to develop hyperthrophic scar;
Exclusion criteria: sensitivity to benzoyl peroxide; no regular visits; using co-treatments.
Age
From 12 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Univerity of Medical Sciences
Street address
Isfahan- HezaJerib- Isfahan Uni Med Sci
City
Isfahan
Postal code
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
ir.mui.rec.1394.3.426
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 Index
Timepoint
Befor and 1, 2, 3 months after initiation and 1 month after the last visit
Method of measurement
Calculating corresponding formula based on the number of injuries
Secondary outcomes
1
Description
Acne Global Severity Scale
Timepoint
Before, 1,2,3 month after treatment and 1 month after final treatment
Method of measurement
Calculating corresponding formula based on the number of injuries
Intervention groups
1
Description
Control group receives topical benzoyl peroxide 5% only
Category
Treatment - Other
2
Description
Treatment group receives intense pulsed light therapy in addition to topical treatment of benzoyl peroxide 5% and
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Maryam Gholami
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mokhtari
Street address
Isfahan- HezarJerib- Isfahan Uni Med Sci
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan Uni Med sci
Full name of responsible person
Maryam Gholami
Position
Student
Other areas of specialty/work
Street address
Isfahan Uni Med sci- Faculty of Medicine
City
Isfahan
Postal code
Phone
+98 913 307 1845
Fax
Email
maryam.gholami712@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Univerity of Medical Sciences
Full name of responsible person
ّFatemeh Mokhtari
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of dermatology, Al-Zahra Hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3625 5555
Fax
Email
f-mokhtari@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Univerity of Medical Sciences
Full name of responsible person
Tohid Jafari Koshki
Position
Student
Other areas of specialty/work
Street address
Department of Biostatistics and Epidemiology, Isfahan University of medical sciences, Isfahan, Iran
City
Isfahan
Postal code
5447135114
Phone
+98 914 492 6048
Fax
+98 01
Email
tjkoshki@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)