| CTRI Number |
CTRI/2018/12/016588 [Registered on: 10/12/2018] Trial Registered Prospectively |
| Last Modified On: |
10/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment for melasma by metformin lotion |
|
Scientific Title of Study
|
Topical metformin in the treatment of melasma: A preliminary clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Kumar A C |
| Designation |
POST GRADUATE |
| Affiliation |
Hassan institute of medical sciences |
| Address |
Department of Dermatology
Hassan institute of medical sciences
Hassan
SriChamarajendra hospital campus,HIMS,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
09738894366 |
| Fax |
|
| Email |
naveenac111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BC Ravikumar |
| Designation |
Professor |
| Affiliation |
Hassan institute of medical sciences |
| Address |
Department of Dermatology
Hassan institute of medical sciences
Hassan
SriChamarajendra hospital campus,HIMS,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448742905 |
| Fax |
|
| Email |
dr.ravikumarbc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Kumar A C |
| Designation |
POST GRADUATE |
| Affiliation |
Hassan institute of medical sciences |
| Address |
Department of Dermatology
Hassan institute of medical sciences
Hassan
SriChamarajendra hospital campus,HIMS,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
09738894366 |
| Fax |
|
| Email |
naveenac111@gmail.com |
|
|
Source of Monetary or Material Support
|
| systopic laboratories pvt. ltd, ranjith nagar,New Delhi -110008 |
|
|
Primary Sponsor
|
| Name |
Hassan institute of medical sciences |
| Address |
Sri Chamarajendra Hospital campus,Hassan |
| Type of Sponsor |
Government medical college |
|
|
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 Naveen Kumar A C |
Sri chamarajendra hospital |
Room no 140,1st floor
Hassan
KARNATAKA |
9738894366
naveenac111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee HIMS Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: 20 patients will be treated with topical metformin.
|
•Topical metformin will be prepared by mixing metformin powder with 70% alcohol and propylene glycol in 30% weight: volume ratio.
Patch test will be done on patients before starting treatment.A small quantity of metformin lotion(0.2 g) will be applied under occlusion on normal skin over upper back and patients will be advised not to disturb that area for 72 hours. After 72 hours, occlusion will be removed and the area is inspected for any reaction. If there is severe erythema /edema/papules/ vesicles/bulla, such patients will be excluded from the study.
Patients who do not develop any signs of irritation or develop only mild erythema, such patients will be recruited for treatment,clinical photographs will be taken and will be advised to apply a thin film of lotion over the affected area on face at night and regular sunscreen in the morning for a period of 8 weeks. |
| Comparator Agent |
Group 2: TCC |
Patients will be advised to apply a thin film of cream over the affected area
on face at night and regular sunscreen in the morning for a period of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having melasma of more than 18 years age.
2) Patients who are not on topical medications for melasma treatment for atleast 2 weeks , 1 month for systemic steroids, 3 months for laser, dermabrasion or
peels.
3) Patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women
2) Patients on oral contraceptives, phenytoin
3) Patients with renal dysfunction.
4) Patients who are allergic to the investigating medications.
5) Patients with acne vulgaris, rosacea. |
|
|
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 |
| safety |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Melasma area and severity index score |
8 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/12/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Melasma is a common acquired pigmentary disorder that manifests as symmetric hyperpigmented macules and patches on the face,more frequently affects women of reproductive age with darker skin type. Melasma poses a therapeutic challenge because of its recalcitrant & recurrent nature.Ideal treatment option for this cosmetically embarrassing condition is effective depigmentation without any adverse effects. Numerous therapeutic modalities have been tried for this condition, triple combination cream(hydroquinone+steroid+tretinoin) remains the gold standard of treatment for this condition, but their prolonged use can result in serious adverse effects.Recent studies have shown that metformin has melanopenic action when applied topically.Hence, this study will be undertaken to evaluate the efficacy and safety of topical metformin and to compare its efficacy with that of triple combination cream (hydroquinone 2%+ tretinoin 0.025% +fluocinolone acetonide 0.01%), which is already proven to be efficacious in the treatment of melasma. Twenty patients in group 1 will be treated with topical metformin, 20 patients in group 2 will be treated with TCC i.e, (hydroquinone 2%+ tretinoin 0.025% +fluocinolone acetonide 0.01%) |