| CTRI Number |
CTRI/2020/02/023471 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
18/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative effects of Dermaroller with Triamcinolone Acetonide v/s Dermaroller with platelet rich plasma v/s Dermaroller alone in treatment of patchy hair loss |
|
Scientific Title of Study
|
A Comparative Study Of Efficacy And Safety Of Microneedling With Triamcinolone Acetonide V/S Microneedling With Platelet Rich Plasma V/S Microneedling Alone In Treatment Of Alopecia Areata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Omkar Kulkarni |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College and Hospital, Aurangabad |
| Address |
Department of Dermatology,
MGM Medical College and Hospital , N-6 CIDCO , Aurangabad, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9405859878 |
| Fax |
|
| Email |
omkarderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anirudha Gulanikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Medical College and Hospital, Aurangabad |
| Address |
Department of Dermatology,
MGM Medical College and Hospital , N-6 CIDCO , Aurangabad, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9822377963 |
| Fax |
|
| Email |
agulanikar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anirudha Gulanikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Medical College and Hospital, Aurangabad |
| Address |
Department of Dermatology,
MGM Medical College and Hospital , N-6 CIDCO , Aurangabad, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9822377963 |
| Fax |
|
| Email |
agulanikar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital
N 6 CIDCO , Aurangabad 431003 |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital Aurangabad |
| Address |
N6 Cidco Aurangabad 431003 |
| 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 Anirudha Gulanikar |
MGM Medical College and Hospital Aurangabad |
Department of Dermatology ( OPD no 256 ) MGM Medical College and Hospital , N 6 CIDCO , Aurangabad 431003
Aurangabad
MAHARASHTRA |
9822377963
agulanikar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Mission Ethical Committee for Reasearch on Human Subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microneedling alone |
Microneedling alone will be done in patient of alopecia areata as a comparator modality. Microneedling with 2.5mm depth will be done at each sitting. 3 such siitings will be done with a gap of 3 weeks inbetween each of them. |
| Intervention |
Microneedling with Platelet Rich Plasma |
Microneedling with a depth of 2.5mm will be done after obtaining platelet rich plasma with concentration of platelets 3-4 times physiological normal , Platelet rich plasma being applied after microneedling at site of lesion just enough to cover lesional surface. 3 such sittings will be done at 3 weeks interval. |
| Intervention |
Microneedling with Triamcinolone acetonide |
Microneedling with 2.5mm depth will be done and Triamcinolone acetonide 2.5mg/ml applied before and after microneedling,a total of 3 such sittings will be done at interval of 3 weeks . |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1) Clinically diagnosed case of Alopecia areata
2) Age 15-59 yrs
3) More than 2 patches of hair loss.
4) Agreeing to sign consent to be included in
|
|
| ExclusionCriteria |
| Details |
1) Local disease such as folliculitis.
2) HIV, Hepatitis B or C, or otherwise immunocompromised patient.
3) History of Diabetes mellitus, Hypertension, any malignancy.
4) Pt under anticoagulant therapy.
5) Pt has taken NSAID within a week of visit .
6) Pregnant or nursing women .
7) Platelets less than 1.5 lakh/cmm.
8) Known allergy to Steroid
9) Any subject treated with a topical, intralesionalor systemic agent likely to cause regrowth in Alopecia areata within the past month
10) Alopecia totalis & universalis
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Growth of hair over patch of alopecia areata
2) improvement in SALT scoring of alopecia areata |
3 sittings at 3 weeks intervals followed by 3 followups at 1 month interval each |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) growth of Pigmented hair over patch of alopecia areta |
3 sittings at 3 weeks intervals followed by 3 followups at 1 month interval each |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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 4 |
|
Date of First Enrollment (India)
|
28/02/2020 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Alopecia areata is an autoimmune hair loss condition which is often difficult to treat. Various treatment modalities are being used which often lead to unpredictable result. This study will use platelet rich plasma , triamcinolone acetonide along with microneedling to enhance drug delivery and have microneedling alone as a comparator modality.
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