| CTRI Number |
CTRI/2019/05/019327 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
25/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of effect of dermaroller with vitamin c serum application for treatment of darkened facsial skin |
|
Scientific Title of Study
|
Effect of microneedling with vitamin c serum application for treatment of melasma |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alisha Mittal |
| Designation |
Junior Resident |
| Affiliation |
Dr D.Y Patil Medical college, Pune |
| Address |
OPD No 14, Department of dermatogy,Dr D Y Patil Medical college, Pune
Sant tukaram nagar, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
7042096656 |
| Fax |
|
| Email |
alisha091@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Deo |
| Designation |
Professor |
| Affiliation |
Dr D.Y Patil Medical college, Pune |
| Address |
OPD No 14, Department of dermatogy,Dr D Y Patil Medical college, Pune
Sant tukaram nagar, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9890233909 |
| Fax |
|
| Email |
deokirti2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alisha Mittal |
| Designation |
Junior Resident |
| Affiliation |
Dr D.Y Patil Medical college, Pune |
| Address |
OPD No 14, Department of dermatogy,Dr D Y Patil Medical college, Pune
Sant tukaram nagar, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
7042096656 |
| Fax |
|
| Email |
alisha091@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D.Y Patil Medical college, Pune |
|
|
Primary Sponsor
|
| Name |
Alisha Mittal |
| Address |
Old Girls Hostel, Dr D.Y Patil Medical college, Pimpri,Pune |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 |
| Alisha Mittal |
Dr D.Y Patil Medical college |
OPD no 14,Department of dermatology,Dr D.Y Patil Medical college, Pimpri, Pune, Maharashtra
Pin 411018
Pune
MAHARASHTRA |
7042096656
alisha091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Sub- Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, (2) ICD-10 Condition: L814||Other melanin hyperpigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling with vitamin c serum application |
Microneedles with 0.5 mm length and 192 needles will be used.
Face will be wiped with saline soaked gauze and let it dry.
Skin will be stretched and microneedling will be carried out the in vertical, horizontal and both diagonal directions 4-5 times over the pigmented area followed by Vitamin C (20%) serum application.
The procedure is to be repeated 3 times in similar way.
The subjects will be instructed to follow strict photo-protective measures.
They will be asked to apply vitamin c serum daily at night on pigmented area.
Repeat sittings will be done in interval of 15 days.
Photographs will be taken for assessment before 1st sitting of the procedure and at the end of 4th sitting.
|
| Comparator Agent |
Topical vitamin c serum application |
Patient will be asked to apply vitamin c serum daily at night on pigmented area.
Photographs will be taken for assessment before 1st sitting of the procedure and at the end of 4th sitting
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients of mixed and epidermal melasma reporting to OPD.
2) Patient willing to participate and have signed the informed consent
3)Patients who are on no concurrent systemic or topical treatment for melasma.
|
|
| ExclusionCriteria |
| Details |
1)Patients with dermal melasma
2)Patients with fever or signs of any systemic or local inflammation or infection.
3)Inability to come for regular follow-ups.
4)Patients not willing to participate in the study
5)Moderate to severe chronic skin disease such as eczema and psoriasis
6)Blood dyscrasias, patients on anticoagulant therapy
7)Extreme keloidal tendency
8)Patient on chemo/radiotherapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvment in Melasma Area Severity Index score |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any effect on quality of life |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
05/06/2019 |
| 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="0"
Months="4"
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)?
|
|
Brief Summary
|
This study is Randomized controlled trial of effect of microneedling with vitamin c serum application for treatment of melasma.Vitamin C inhibits melanogenesis, promotes collagen biosynthesis, prevents free radical formation and accelerates wound healing. It is best used after techniques that enhances transdermal delivery of agents such as microneedling.
Microneedling is a very simple, safe, effective, and minimally invasive therapeutic technique which involves superficial and controlled puncturing of skin by rolling with miniature fine needles. It is widely used as a transdermal delivery system for therapeutic drugs and vaccine
The study will be conducted for a period of 4 months at Dr D.Y Patil medical college, Pune. The primary outcome will be improvement in MASI score and secondary will be improvement in quality of life.
|