Efficacy of intense pulsed light combined with topical erythromycin solution 2% versus topical erythromycin solution 2% alone in the treatment of persistent facial erythematous acne macules
Background: There is a necessity for newer acne treatments. Intense pulsed light (IPL) technology has been used for this purpose but there are limited studies in this field. We wanted to examine the efficacy of IPL for the treatment of persistent erythematous macules that remain after inflammatory lesions of facial acne. Methods: We employed 35 patients between January 2010 and June 2011, and our study was terminated in October 2011. The right side of their face was treated by IPL combined with topical erythromycin lotion 2% but topical erythromycin lotion 2% alone was applied on the left side. A non-treating dermatologist counted the number of erythematous macules before every IPL session, and one and three months after the last session
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201178656N1
Registration date:2012-01-21, 1390/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-21, 1390/11/01
Registrant information
Name
Amin Kharaziha Isfahani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1627 7732
Email address
kharazi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2011-06-30, 1390/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intense pulsed light combined with topical erythromycin solution 2% versus topical erythromycin solution 2% alone in the treatment of persistent facial erythematous acne macules
Public title
Efficacy of IPL in acne
Purpose
Treatment
Inclusion/Exclusion criteria
In our study inclusion criterions were the presence of at least 5 persistent erythematous macules on every side of the patients' face and these macules should be complication of inflammatory acne lesions and these macules should be persistent even with receiving at least two months of standard treatments. Exclusion criterions were oral retinoid use from 6 months before the study, necessity of systemic treatments (i.e. nodulocystic or scarring acne), history of keloid, vitiligo, drugs that exacerbate or remit acne lesions, history of skin cancer, photosensitivity disorders and history of poor wound healing such as diabetes mellitus
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethics Committee
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-03-14, 1388/12/23
Ethics committee reference number
389255
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
Persistent erythematous macules of facial acne
Timepoint
Before the study, before every IPL session, 1 and 3 months after last IPL session
Method of measurement
Counting and photography
Secondary outcomes
1
Description
Erythema
Timepoint
One week after every IPL session
Method of measurement
Questionnaire
2
Description
Pain
Timepoint
One week after every IPL session
Method of measurement
Questionnaire
3
Description
Photosensitivity
Timepoint
One week after every IPL session
Method of measurement
Questionnaire
4
Description
Swelling
Timepoint
One week after every IPL session
Method of measurement
Questionnaire
5
Description
Blister
Timepoint
One week after every IPL session
Method of measurement
Questionnaire
6
Description
Crusting
Timepoint
One week after every IPL session
Method of measurement
Questionnaire
Intervention groups
1
Description
Intetrvention group is right side of face. we done 3 IPL sessions with 2 weeks interval and also advised the patients to apply topical erythromycin lotion 2% twice daily from start of the study until 3 months after the third IPL session. the setting of IPL was: 530-1100nm wavelength, one pass, fluence of 14-16 J/cm2, and program of 14-18.
Category
Treatment - Devices
2
Description
Control group was left side of face that was only treated by topical erythromycin lotion2% twice daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Isfahan University of Medical Sciences
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Peyman Adibi
Street address
Isfahan University of Medical Sciences, al-zahra hospital
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 University of Medical Sciences
Full name of responsible person
Dr Amin Kharaziha Isfahani
Position
Dermatologist
Other areas of specialty/work
Street address
Isfahan University of Medical SciencesHazar jarib ave.
City
Isfahan
Postal code
Phone
+98 31 1792 2406
Fax
Email
kharazi@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gita Faghihi
Position
Dermatologist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2406
Fax
Email
faghihi_g@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Amin Kharaziha Isfahani
Position
Dermatologist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences , al-zahra hospital
City
Isfahan
Postal code
Phone
+98 31 1627 7732
Fax
Email
kharazi@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)