Comparison of the effectiveness of Q-switch laser and peeling with TCA in the treatment of lentigo solar dorsal hands
Design
A randomized clinical trial with a random number table without blinding was followed in phase 2 with 45 patients, followed by a follow-up for 4 weeks.
Settings and conduct
In this study, 45 patients randomized with bilateral hand lentigo were selected. Then 35% TCA was randomly rubbed on all the lesions of one hand with the tip of a cotton swab. All other hand lesions were exposed to the Q SWITCH-ND: YAG 532 laser. Similar interventions were performed the next time with an interval of 4 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: symmetrical solar lentigo; based on clinical diagnosis; behind both hands. Exclusion criteria: associated physical illness, treatment in the last 6 months, drugs or alcohol consumption in the last 6 months, pregnancy or breastfeeding in women.
Intervention groups
Intervention group 1: Q-switch laser. Intervention group 2: peeling with TCA
Main outcome variables
Degree of pigmentation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201216049734N1
Registration date:2021-03-04, 1399/12/14
Registration timing:registered_while_recruiting
Last update:2021-03-04, 1399/12/14
Update count:0
Registration date
2021-03-04, 1399/12/14
Registrant information
Name
Azam Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
dr.azam.mosavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-01, 1399/12/11
Expected recruitment end date
2021-06-24, 1400/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Q switch laser and TCA peeling in the treatment of solar lentigo in the dorsal hands
Public title
Treatment of solar lentigo using Q-switch laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with solar lentigo based on clinical diagnosis
Bilateral and symmetrical lesions
Exclusion criteria:
associated physical illness
treatment in the last 6 months
Existence of substance or alcohol in the last six months
Pregnancy or breastfeeding in women
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
After preparing a list of appropriate patients, based on the inclusion criteria, 45 patients were selected and randomized based on a table of random numbers, in such a way that the laser was used for even-numbered numbers on the left hand and TCA solution was used on the opposite hand. The opposite was performed for odd numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Sofe Street, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.MUI.MED.REC.1399.744
Health conditions studied
1
Description of health condition studied
solar lentigo
ICD-10 code
L81.4
ICD-10 code description
other melanin hyperpigmentation
Primary outcomes
1
Description
Degree of pigmentation
Timepoint
At the beginning of the study and the sixteenth week
Method of measurement
Clinical examination
2
Description
Pain
Timepoint
Fourth and eighth week
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Hyperpigmentation and hypo pigmentation
Timepoint
At the beginning of the study and the sixteenth wee
Method of measurement
clinical
Intervention groups
1
Description
Intervention group 1: On all lesions of one hand were rubbed with 35% TCA solution with the tip of a cotton swab.
Category
Treatment - Other
2
Description
Intervention group 2: All other hand lesions were exposed to the Q SWITCH-ND: YAG 532 laser (7-1 j / cm2energy and 3-4mmspot size).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Azam Mosavi
Street address
Sofeh Street, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Email
dr.azam.mosavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azam Mosavi
Street address
Safa Street, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Email
dr.azam.mosavi@gmail.com
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
Azam Mosavi
Position
Dermatologist Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sofeh Street, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Email
dr.azam.mosavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Ireji
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sofeh Street, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Email
iraji@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azam Mosavi
Position
Dermatologist Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Safa Street, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Email
dr.azam.mosavi@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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available