Objectives: The purpose of this study is comparison efficacy of PDL laser with 532 nm laser in treatment of solar lentigo. Design: This study will be conducted in 20 patients with facial or hand lentigines that will be admitted to Emam Khomeini hospital. Inclusion criteria: patients with at least two solar lentigo; Skin type 2-4. Exclusion criteria: History of photo therapy; History of scar formation; History of any treatment of lentigo, vitiligo, psoriasis. Intervention: The patients will randomly be allocated into two groups. Group I: Patients will receive PDL laser one to three times with seven joules per cubic centimeter energy during five to ten minutes. Group II: Patients will receive 532 nm laser one to three times with five joules per cubic centimeter energy during five to ten minutes. Main outcome measures: Pigmentation Grade Before and one month after the intervention will be measured according to degree of reducing pigmentation: poor; medium; excellent. Also the pain is measured in the time of intervention with Visual Analogue Scale.
General information
Acronym
Effect of PDL laser in treatment of lentigo
IRCT registration information
IRCT registration number:IRCT2016123131671N1
Registration date:2017-04-28, 1396/02/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-28, 1396/02/08
Registrant information
Name
Arezou Bagherzadeh
Name of organization / entity
Ahvaz jondishapur university of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8068
Email address
bagherzadeh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2017-08-30, 1396/06/08
Expected recruitment end date
2018-03-30, 1397/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of PDL laser via 532 nm laser in treatment of solar lentigo
Public title
Treatment of solar lentigo with PDL laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients with at least two solar lentigo; Skin type 2-4; Having greater than 15 years old.
Exclusion criteria: Pregnancy;History of photo therapy; History of scar formation; History of any treatment of lentigo, vitiligo, psoriasis; UN real expectation of laser treatment.
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethic Commitee of Ahvaz Jundishapur University of Medical Sciencses
Street address
No 3, University street, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Approval date
2014-06-16, 1393/03/26
Ethics committee reference number
ajums.REC.1393.422
Health conditions studied
1
Description of health condition studied
Skin lesions of lentigo
ICD-10 code
L81.4
ICD-10 code description
Melanin Hyperpigmentation
Primary outcomes
1
Description
Pigmentation Grade
Timepoint
Before and one month after the intervention
Method of measurement
By reducing pigmentation: poor; medium; excellent
2
Description
Pain
Timepoint
In the time of intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Scar formation
Timepoint
A month after the intervention
Method of measurement
Observational
2
Description
Hyper-pigmentation and hypopigmentation after inflammation
Timepoint
A month after the intervention
Method of measurement
Observational
Intervention groups
1
Description
Laser Type: PDL
The amount of energy: Seven joules per cubic centimeter
Laser spot size: Five Millimeter
Frequency of use: One to three times.
Duration: Five to ten minutes
Country: United States
Category
Treatment - Other
2
Description
Laser Type: Nd:YAG Laser(Neodymium-doped Yttrium Aluminium Garnet)
The amount of energy: Five joules per cubic centimeter
Laser spot size: Three Millimeter
Frequency of use: One to three times
Duration: Five to ten minutes
Country: United States
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Seyed Mohammad Radmanesh
Street address
No. 4, Ave. 1, Kianpars Blvd.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Radmanesh
Street address
No. 5, Ave. 4, Kianpars Blvd.
City
Ahvaz
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, Ahvaz University of Medical Sciences