| CTRI Number |
CTRI/2024/05/066757 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Chemical Peel, Qs ND YAG laser] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of 1064 nm Q Switched Nd-YAG laser and glycolic acid peel in patients with macular amyloidosis |
|
Scientific Title of Study
|
A comparative study on the efficacy and dermoscopic changes in 1064 nm Q Switched Nd-YAG laser versus glycolic acid peel in Macular Amyloidosis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Gulshan Kumar Sirohi |
| Designation |
Resident Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Department of Dermatology,
Command Hospital Air Force Bangalore,
Agram Post,
Old Airport Road
Bangalore
KARNATAKA
560007
India |
| Phone |
8892266650 |
| Fax |
08025579151 |
| Email |
crazybasketballer.gulshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Debdeep Mitra |
| Designation |
Professor Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Department of Dermatology,
Command Hospital Air Force Bangalore,
Agram Post,
Old Airport Road
Bangalore
KARNATAKA
560007
India |
| Phone |
8811851830 |
| Fax |
08025579151 |
| Email |
debdeep5000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gulshan Kumar Sirohi |
| Designation |
Resident Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Department of Dermatology,
Command Hospital Air Force Bangalore,
Agram Post,
Old Airport Road
Bangalore
KARNATAKA
560007
India |
| Phone |
8892266650 |
| Fax |
08025579151 |
| Email |
crazybasketballer.gulshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Air Force Bangalore , Agaram Post, Old Airport Road, Bengaluru - 560007 |
|
|
Primary Sponsor
|
| Name |
Command Hospital Air Force Bangalore |
| Address |
Agaram Post, Old Airport Road, Bengaluru - 560007 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gulshan Kumar Sirohi |
Command Hospital Air Force Bangalore |
Department of Dermatology, Agaram Post, Old Airport Road, Bangalore - 560007
Bangalore
KARNATAKA |
8892266650
08025579151
crazybasketballer.gulshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital (Air Force) Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E854||Organ-limited amyloidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1064 nm Q switched Nd - YAG laser |
For Q-switched Nd-YAG laser, IDS Q10 will be used. Only one group of patients, randomly assigned (QS Nd-YAG group) will be irradiated. The laser parameters for the present study will be set as follows: wavelength of 1064 nm, spot size of 6 mm, fluence of 4.0-5.0 J/cm2, and a repetition rate of 10 Hz. The endpoint of irradiation will be the appearance of a mild general erythema in the irradiated area, after 2-3 passes with an approximate 20% overlap. Treatment will be performed once a month for 4 consecutive months. After irradiation, the patients will be asked to wash the area with cold water. All patients will be advised strict sun protection and liberal use of emollients and broad-spectrum sunscreen with an SPF of 30. Total duration of intervention - 3 to 4 months. |
| Comparator Agent |
Glycolic acid peel |
GA peel will be used in patients of this group. After degreasing, 40% GA peel will be carried out for a period of 20
to 30 s and will be kept for a period of 2 5 min (First peel, 2 min; second peel, 3 min; third peel, 4 min; and fourth peel, 5 min; separated by 1 month intervals). The peel will be terminated by the dilutional effect of washing with cold water-soaked gauze pads in the same sequence as the application. The endpoint of the treatment session will be the attainment of the stipulated period or appearance of erythema, All
patients will be advised strict sun protection and liberal use of emollients and broad-
spectrum sunscreen with an SPF of 30. GA peels will be repeated once in 4 weeks and 4 such sessions will be given.Total duration of intervention - 3 to 4 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged ≥18 years of either sex, Patients with macular amyloidosis,Patients who are not on any topical/oral/laser therapy for last 01 month, Patients with written informed consent by self or by guardian |
|
| ExclusionCriteria |
| Details |
Patient with history of any treatment for macular amyloidosis in last 01 month, Pregnant females, Photosensitive dermatoses, Patients with known hypersensitivity to chemical peels, Patients with unrealistic expectations, Patients will be dropped from the study if any adverse effect noticed after test patch |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Color score will be used before and 1 month after the treatment in both the groups |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS (Visual Analogue Scale) - Will be done 1 month after completion of treatment |
6 months |
| Dermoscopic findings |
6 months |
| Subjective improvement |
6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, open label, comparative study on the efficacy and dermoscopic changes in 1064 nm Q switched Nd-YAG laser and glycolic acid peel in macular amyloidosis that will be conducted in a tertiary care center in India. The primary outcome will compare the color score which will be used before and 1 month after the treatment in both the groups. The secondary outcomes will be Visual Analogue Score - will be done before and 1 month after completion of treatment, dermoscopic findings before and 1 month after completion of treatment and subjective improvement 1 month after completion of treatment. |