Efficacy of Photodynamic therapy with topical indocyanine green in the treatment of Keloidal lesions
Design
clinical trial, pilot study
Settings and conduct
before the therapeutic sessions, small amount of ICG ointment applied in lateral side od arm and the patient being informed not to touch or rinse the place. after 48 hours we look the place for any kind of skin reactions and if there was no skin reactions< the patient is allowed to enter to trial.
first a basic photograph of the lesion being taken and the dimensions are determined. lesions being covered with ICG ointment with 1mm thickness on top and 5mm around and its covered with biofilm for 1 hour. then the lesions being wiped off and it goes under photodynamic therapy with source LumaCare with 730 nm probe every 2 weeks and total of 6 sessions.
patients being assessed in 6 and 12 weeks after the treatment sessions for any recurrences.
the place we do the trial is in dermatology outpatient clinic of imam Reza hospital in Mashhad
Participants/Inclusion and exclusion criteria
The patients with minimum age of 18 years old are being selected based on dermatologist diagnosis as having idiopathic keloids. They have no history of any medical treatments for their lesions in 3 last months. only lesions that are located on trunk, extremities, back and buttock are being selected.
Intervention groups
patients who undergo using indocyanine green ointment and photodynamic therapy
Main outcome variables
determining efficacy of Photodynamic therapy with topical indocyanine green in the treatment of Keloidal lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201221049780N1
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Sara Fakhraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 0858
Email address
sarai.fakhraei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Photodynamic therapy with topical Indocyanine green in the treatment of Keloidal lesions
Public title
Efficacy of Photodynamic therapy with topical Indocyanine green in the treatment of Keloidal lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the patients are selected based on dermatologist diagnosis as having idiopathic keloids
minimum age for being selected is 18 years old
patients have no history of any medical treatments for their lesions at least in 3 months
lesions are on trunk, extremities, back and buttock
Exclusion criteria:
any skin disease or abnormality around the lesion for example dermatitis, bacterial or fungal infections
pregnancy
lactation
lesions on face and genitalia
history of any medical treatments for their lesions in 3 last months
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
2 keloidal lesions of any patients are being selected
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2020-12-21, 1399/10/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.542
Health conditions studied
1
Description of health condition studied
keloid
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
improvement of keloidal lesions based on POSAS score
Timepoint
before the trial, every month after starting trial, in 6th and 12th weeks after finishing the trial
Method of measurement
Patient and Observer Scar Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients under treatment with indocyanine green 0.2% ointment and photodynamic therapy after 1 hour, every 2 weeks for total of 6 sessions
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Reza Hospital of Mashhad City