Comparison of Effectiveness of Hydroquinone 4% and Fractional CO2 Laser combination vs. Hydroquinone 4% Monotherapy in women from the age range of 20-50 years with melasma.
To evaluate the efficacy of fractional CO2 laser in combination with topical therapy in melasma treatment.
Design
A paralell group, single-blinded, blocked randomization clinical trial, design of 40 patients, enrolled between February 2015 and march 2016, and followed at three-week intervals and one and three months after the last laser session
Settings and conduct
Each side of the face was randomly allotted to either topical hydroquinone 4% or combination of topical hydroquinone 4% and Fractional CO2 laser. The patients received three sessions of laser therapy at 3-week intervals. They were asked to use hydroquinone 4% on both sides for 3 months after the last laser session during follow-up.
The clinical improvement was measured by an impartial blinded physician.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Female,age range of 20-50 years, Fitzpatrick skin types II-V, bilateral melasma
Exclusion criteria: history of receiving laser therapy and topical therapeutic agents in the previous three months, Isotretinoin in the past six months, OCP, other bleaching creams, phenytoin, phototoxic and photoallergic drugs, pregnancy and lactating.
Intervention groups
For each patients One cheek is considered as the control (Hydroquinone group) and the other cheek as the experiment (laser and Hydroquinone group).
Main outcome variables
Darkness of hyperpigmentations
Homogeneity of hyperpigmentations
response to treatment due to the percentage improvement in the lesions
patient's satisfaction with the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171222037987N1
Registration date:2018-06-30, 1397/04/09
Registration timing:retrospective
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Farahnaz Fatemi Naeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 4781
Email address
fatemi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-10-06, 1394/07/14
Actual recruitment start date
2015-02-04, 1393/11/15
Actual recruitment end date
2016-03-10, 1394/12/20
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Hydroquinone 4% and Fractional CO2 Laser combination vs. Hydroquinone 4% Monotherapy in women from the age range of 20-50 years with melasma.
Public title
Combination of Hydroquinone and Fractional CO2 Laser vs. Hydroquinone Monotherapy in Melasma Treatment: A Randomized Split-face Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients
Age range of 20-50 years
Fitzpatrick skin types II-V
Bilateral melasma on cheeks
Exclusion criteria:
History of receiving laser therapy and topical therapeutic agents in the previous three months
History of receiving Isotretinoin in the past six months
History of receiving OCP, other bleaching creams, phenytoin, phototoxic and photoallergic drugs
Pregnancy
Lactating
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
for each patient one cheek is considered as the control and the other cheek as the experiment
Actual sample size reached:
37
More than 1 sample in each individual
Actual sample size in each individual:
2
for each patient one cheek was considered as the control and the other cheek as the experiment
Randomization (investigator's opinion)
Randomized
Randomization description
For each patient one cheek was considered as the control (Hydroquinone group) and the other cheek as the experiment (laser and Hydroquinone group) according to blocked randomization which was generated by a third independent person who was not involved in the study. Participants were randomized in to group A (right cheek as the experiment) and group B (left cheek as the experiment) within then blocks of four each. Randomly generated treatment allocations were concealed in the forty envelopes which were sequentially numbered and opened only after each patient was consented to enter the trial.
Blinding (investigator's opinion)
Single blinded
Blinding description
the main investigators, data analysors and out come assessors were blinded.
Severity of the melasma lesions was assessed objectively by the main investigator who was blinded to the treatment being given on each side and consultant dermatologist who was blinded to the type of treatments applied and aim of the study.
Furthermore, response to treatment was evaluated subjectively by the main investigator and another consultant dermatologist who was blinded to the treatment being given on each side and the aim of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences, Hezar Jerib Ave
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2013-01-20, 1391/11/01
Ethics committee reference number
391095
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Severity of the melasma lesions was assessed objectively based on Darkness (D) and Homogeneity (H) using a 7-point scale (0-6).
Timepoint
The darkness and homogeneity scores were obtained in the first visit and the 3 laser sessions at three-week intervals and the follow-up sessions at 1 and 3 months after the last laser session.
Method of measurement
darkness and homogeneity : 7-point scale(compare with the sample) patient's satisfaction with the treatment :visual analogue scale (VAS) by scoring between 0 and 10 response to treatment : physician global assessment
Secondary outcomes
1
Description
patient's satisfaction with the treatment.
Timepoint
3 months after the last laser session.
Method of measurement
visual analogue scale (VAS) by scoring between 0 and 10.
Intervention groups
1
Description
Intervention group: for each patient one side of the face was randomly allotted to topical hydroquinone 4% and Fractional CO2 laser (combination therapy group). Patients received three sessions of laser therapy at 3-week intervals with the Dios instrument. (Laser fluence of 5 J/cm2, Dot cycle of 6 and Pixel pitch of 2).
Category
Treatment - Drugs
2
Description
Control group: for each patient one side of the face was randomly allotted to topical hydroquinone 4% (monotherapy group). Hydroquinone 4% was applied during the study and maintained for 3 months after the last laser session.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farahnaz Fatemi Naeini
Street address
Department of Dermatology, Alzahra Hospital , Soffeh Blvd, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2087
Email
fatemi@med.mui.ac.ir
Web page address
http://med.mui.ac.ir/?q=post/post
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
4th building, Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 2252
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Farahnaz Fatemi Naeini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Alzahra Hospital, Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2087
Email
fatemi@med.mui.ac.ir
Web page address
http://med.mui.ac.ir/?q=post/post
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farahnaz Fatemi Naeini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Alzahra Hospital, Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2087
Email
fatemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farahnaz Fatemi Naeini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Alzahra Hospital, Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2087
Email
fatemi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available