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Comparison of the efficacy of fractional co2 laser alone and in combination with topical latanoprost drop in repigmentation of hypopigmented scars

Protocol summary

Summary
The goal of this study is to compare between efficacy of fractional co2 laser alone and in combination with topical latanoprost drop in repigmentation of hypopigmented scars. This study is a double blind(both patients and practitioners were blind to the trial), randomized, placebo-controlled, clinical trial. This study contain two group that 14 patients present in each group(in total 28 patients). In either group, 6 session of laser treatment with one month interval were performed. in first group, in addition to laser treatment, topical latanoprost drop is used twice daily, and in second group distill water drop (in package identical to latanoprost) is used twice daily as placebo. Inclusion criteria include age between 15 to 50 years, skin phototype 1 to 4, negative history of systemic retinoid therapy(isotretinoin and acitretin) in recent 6 month. Exclusion criteria include history of hypersensitivity reaction to topical latanoprost, pregnancy, lactation. The patients were divided in two group, using table of randomization. Prior to treatment, all patients were photographed. 3 month after last session of laser treatment the patients were assessed by a dermatologist who was not aware of method of treatment.The assessment was done by using of quartile scale (0-25%,25-50%,50-75%,75-100%), then the results of two trial groups were compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013123016002N1
Registration date: 2014-03-19, 1392/12/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Reza Rezaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2435
Email address
reza.rezaei@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-28, 1392/02/08
Expected recruitment end date
2014-01-26, 1392/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of fractional co2 laser alone and in combination with topical latanoprost drop in repigmentation of hypopigmented scars
Public title
Treatment of hypopigmented scar (ulcer, burning and etc) with laser and latanoprost drop
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 15 to 50 years, skin phototype 1 to 4, negative history of systemic retinoid therapy(isotretinoin and acitretin) in recent 6 month. Exclusion criteria: history of hypersensitivity reaction to topical latanoprost, pregnancy, lactation
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Aven, Isfahan
City
Isfahan
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
392019

Health conditions studied

1

Description of health condition studied
Hypopigmented scar
ICD-10 code
L90.5
ICD-10 code description
Scar NOS

Primary outcomes

1

Description
Repigmentation of hypopigmented scar
Timepoint
baseline, monthly for 6 months, 3month after last session of laser treatment
Method of measurement
Physician observation and scoring according to quartile scale (0-25%,25-50%,50-75%,75-100%)

Secondary outcomes

1

Description
side effect of latanoprost drop include hypersensitivity reaction
Timepoint
monthly
Method of measurement
clinical evaluation

2

Description
side effects of laser include erythema, pain and burning sensation
Timepoint
monthly
Method of measurement
clinical evaluation

Intervention groups

1

Description
6 session of fractional co2 laser treatment with one month interval were done(with fluence of 400mj/cm2).In addition to laser therapy, distill water drop was applied twice daily as placebo.
Category
Treatment - Other

2

Description
6 session of fractional co2 laser treatment with one month interval were done(with fluence of 400mj/cm2).In addition to laser therapy, topical latanoprost drop was applied twice daily.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-zahra hospital, dermatology clinic
Full name of responsible person
Dr. Reza Rezaei
Street address
Dermatology group, Al-zahra hospital, Soffeh Blvd, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Esfandiari, Vice chancellor for research, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Aven, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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. Reza Rezaei
Position
Resident of dermatology
Other areas of specialty/work
Street address
Dermatology group, Al-zahra hospital, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
reza.rezaei@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. Amirhossein Siadat
Position
Assistant professor of Dermatology
Other areas of specialty/work
Street address
Dermatology group, Al-zahra hospital, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
amirhossein1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Reza Rezaei
Position
Resident of dermatology
Other areas of specialty/work
Street address
Dermatology group, Al-zahra hospital, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
reza.rezaei@resident.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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