| CTRI Number |
CTRI/2023/11/060091 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
20/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF TWO LASER INTERVENTIONS IN THE TREATMENT OF IDIOPATHIC FACIAL HIRSUTISM |
|
Scientific Title of Study
|
A RANDOMISED PROSPECTIVE SPLIT FACE STUDY COMPARING THE EFFICACY AND SAFETY OF DIODE LASER MONOTHERAPY (810nm) VS SEQUENTIAL THERAPY OF DIODE LASER PLUS LONG PULSED ND YAG LASER(1064nm) IN THE TREATMENT OF IDIOPATHIC FACIAL HIRSUITISM |
| 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 Maitreyee Panda |
| Designation |
Professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
IMS AND SUM
HOSPITAL K 8
KALINGA NAGAR
SHAMPUR
BHUBANESHWAR
Khordha
ORISSA
Khordha
ORISSA
751003
India |
| Phone |
9840264514 |
| Fax |
|
| Email |
pandamaitreyee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maitreyee Panda |
| Designation |
Professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
IMS AND SUM
HOSPITAL K 8
KALINGA NAGAR
SHAMPUR
BHUBANESHWAR
Khordha
ORISSA
Khordha
ORISSA
751003
India |
| Phone |
9840264514 |
| Fax |
|
| Email |
pandamaitreyee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adithya Prakash |
| Designation |
PG student |
| Affiliation |
IMS and SUM Hospital |
| Address |
IMS AND SUM
HOSPITAL K 8
KALINGA NAGAR
SHAMPUR
BHUBANESHWAR
Khordha
ORISSA
Khordha
ORISSA
DR ADITHYA PRAKASH
India |
| Phone |
9840264514 |
| Fax |
|
| Email |
prakashadithya14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IADVL |
| Address |
314-315,
3rd Floor KM Trade Tower,
H 3, Sector 14,
Kaushambi, Ghaziabad,
Uttar Pradesh. 201010 |
| Type of Sponsor |
Other [IADVL Research Grant] |
|
|
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 MAITREYEE PANDA |
IMS AND SUM Hospital |
K 8 KALINGA NAGAR
SHAMPUR
BHUBANESHWAR
Khordha
ORISSA
Khordha
ORISSA |
9437218952
prakashadithya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,IMS AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L680||Hirsutism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIODE LASER MONOTHERAPY |
The diode laser works by emitting a light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which damages the hair follicles that produce hairs. This damage inhibits or delays future hair growth.
This type of laser is particularly effective for darker terminal hair and can cover large areas quickly, making it a practical choice for treating large body areas. |
| Intervention |
SEQUENTIAL THERAPY WITH DIODE LASER(810NM) AND LONG PULSED ND YAG LASER(1064NM) |
The combined use of diode laser and long-pulsed Nd:YAG laser in the treatment of hirsutism can offer a comprehensive approach to hair removal, addressing different types of hair and skin.
The diode laser is effective for darker terminal hair and can cover large areas quickly1. It works by emitting a light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which damages the hair follicles that produce hairs. This damage inhibits or delays future hair growth1.
On the other hand, the long-pulsed Nd:YAG laser is safe for all skin types, including tanned patients. It works on the principle of selective photothermolysis, where laser energy is selectively absorbed by the hair follicle, causing its destruction. This laser can also be used without any problems with pigment types III to VI.
By combining these two lasers, a practitioner can effectively treat a wider range of hair types and skin tones, offering a more comprehensive treatment for hirsutism. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients of facial hirsutism aged between 18 and 45 years .
2. Failure to conventional therapy.
|
|
| ExclusionCriteria |
| Details |
1. Grade 1 hair(Fine vellus hair)
2. Any previous laser treatment to the study area within the last 6 months.
3. Any hormonal dysfunction, waxing, depilation,
electrolysis or bleach use within six weeks of entry into the study.
4. A history of keloid scarring.
5. Pregnancy.
6. Immunosuppression.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Diode laser as monotherapy vs Efficacy of sequential therapy of diode laser plus long pulsed Nd YAG laser(1064nm) in the treatment of idiopathic facial hirsutism |
Follow up monthly once for 6 months and every 2 monthly for 4 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Diode laser monotherapy vs sequential therapy of diode laser plus long pulsed Nd YAG laser(1064nm) in the treatment of idiopathic facial hirsutism. |
At the end of follow up that is at 10 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2023 |
| 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="1"
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
|
·
The patients meeting all the
inclusion criteria and not meeting any exclusion criteria shall be considered
to participate in the study.
·
A detailed history including
the duration of disease, associated medical conditions, treatment history and
family history is to be taken.
·
The patients are randomized
according to computer generated random number sequence and allocated to two
interventional groups.
·
One group will be treated with
Diode laser (810nm)
·
The other group will be treated
sequentially with diode laser(810nm) and Long pulse Nd-YAG laser (1064nm)
·
The outcome (efficacy) will be
evaluated by seeing the improvement in visual analog scale, subject self-
assessment, physician and subject global aesthetic improvement and Ferriman
Galleway scoring.
·
Clinical images will be taken
at the starting of therapy and at monthly intervals to look for the improvement,
with due care that the patient’s identity is not revealed.
|