| CTRI Number |
CTRI/2018/10/016214 [Registered on: 30/10/2018] Trial Registered Prospectively |
| Last Modified On: |
04/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness and safety of Minichek in male patients with hairfall. |
|
Scientific Title of Study
|
An open-label, single arm non-comparative study to assess effectiveness and safety of Minichek (Minoxidil 5% ) in the management of Androgenic Alopecia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra G Patwardhan |
| Designation |
Director |
| Affiliation |
Kelkar Nursing Home |
| Address |
Dermatology Department, Room No.1, Kelkar Nursing Home, Prabhat Road Lane No. 1
Near Sanhydri Hospital Pune
Pune MAHARASHTRA 411004 India |
| Phone |
09822057712 |
| Fax |
|
| Email |
ngpatwardhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Narendra G Patwardhan |
| Designation |
Director |
| Affiliation |
Kelkar Nursing Home |
| Address |
Dermatology Department, Room No.1, Kelkar Nursing Home, Prabhat Road Lane No. 1
Near Sanhydri Hospital Pune
Pune MAHARASHTRA 411004 India |
| Phone |
09822057712 |
| Fax |
|
| Email |
ngpatwardhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Narendra G Patwardhan |
| Designation |
Director |
| Affiliation |
Kelkar Nursing Home |
| Address |
Dermatology Department, Room No.1, Kelkar Nursing Home, Prabhat Road Lane No. 1
Near Sanhydri Hospital Pune
Pune MAHARASHTRA 411004 India |
| Phone |
09822057712 |
| Fax |
|
| Email |
ngpatwardhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt. Ltd.
Floor 16, Godrej BKC
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051 |
|
|
Primary Sponsor
|
| Name |
Dr Narendra G Patwardhan |
| Address |
Kelkar Nursing Home
Prabhat Road Lane NO 1
Near Sanhydri Hospital, Pune 411004 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhanashree Bhide |
Dhadphale Nursing Home |
Jangali Maharaj Road, Pune - 411004 Pune MAHARASHTRA |
09822870032
dsbhide@gmail.com |
| Dr Narendra G Patwardhan |
Kelkar Nursing Home |
Prabhat Road Lane No. 1 Near Sanhydri Hospital, Pune 411004 India Pune MAHARASHTRA |
09822057712
ngpatwardhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee (RPIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, (2) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Minichek |
Dosage and Administration
Minoxidil 5%(Minichek 5%) is indicated for the treatment of androgenic alopecia Minichek topical solution is used for external use only. It should be applied twice daily, once in the morning and once at night onto clean, dry scalp, in the hair loss area. The total dose recommended for the study is 1 mL (6 sprays) twice daily. For Minichek to work best, it should be allowed to remain on the scalp for about 4 hours before washing. The night time application should occur 2 to 4 hours before going to bed to allow drying. In case of missing one or two daily doses of Minichek, patient should continue with the next dose. Minoxidil 5% should be applied twice daily (1 mL per application) for a duration of 180 days. Adequate quantity of Study product will be provided to patients during Study Visits. Compliance assessment will be performed at subsequent visits after enrolment.
Study Duration
The total duration of the study will be approximately 1.5 years from the time of enrolment. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients who are ≥18 to ≤45 years of age.
2. Patient suffering from Androgenic alopecia.
3. Patient willing to sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from non-androgenic alopecia.
2. Evidence of dermatological disease as revealed by history, physical examination or laboratory assessment which may interfere with administration or assessment of study medication.
3. Current use of dermatological drugs/preparations which may interfere with study evaluation (Finasteride or any other hormonal treatment).
4. Intolerance to any of the ingredients of the formulation.
5. Current alcohol or drug abuse.
6. Patients viewed by the investigator as not being able to complete the study.
7. Any procedures for hair enhancement and curling or straightening techniques.
8. Patients having participated in a clinical trial in last 30 days.
9. Patients with a history of a migraine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effects of Minichek 5% treatment on change in Anagen/Telogen ratio with
androgenetic alopecia. |
From baseline to day 45, day 90, day 135 and day 180. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effects of Minichek 5% treatment on change in Hair diameter. |
From Baseline to day 45, day 90, day 135 and day 180. |
| Investigator and Patient’s global assessment for effectiveness. |
At day 90 and day 180 on the basis of global photographs.
|
| Investigator and Patient’s global assessment for tolerability. |
At day 45, day 90, day 135 and day 180. |
| Safety assessment of the Minichek 5% in the treatment of AGA. |
At day 45, day 90, day 135 and day 180. |
| Trichoscopy Evaluations of the Minichek 5% treatment at day 45, day 90, day 135 and day 180. |
At day 45, day 90, day 135 and day 180. |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2018 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: Many factors cause clinical hair-loss, or alopecia, including endocrine abnormalities, genetic predisposition, systemic illness, drugs, psychological abnormalities, diet, trauma, infections, autoimmunity, and structural hair defects. Because of the multiplicity of disorders that can result in hair-loss, a thorough history and physical examination are necessary. The causes of androgenic alopecia are well known and easily distinguishable. The primary treatment of hair-loss is still dependent on Minoxidil and Finasteride. No new mainline treatments are available for treatment of hair-loss. Majority of existing Minoxidil preparations are usually solutions with a high percentage of ethyl alcohol. However repeated applications of high ethyl alcohol products lead to severe adverse effects (e.g., scalp dryness, irritation, burning, redness, allergic contact dermatitis Recently ethyl alcohol-free containing formulations have been introduced. However, there is ascarcity of published data on this kind of formulations. So, the current study is to check theeffects of Minichek (Minoxidil 5%) on anagen/telogen ratio and assess the change in severity of hair-loss in patients diagnosed with androgenic alopecia.
Background: Androgenic Alopecia is one of the common chronic problems seen by dermatologists worldwide. Androgenetic alopecia is a common dermatological condition, with potentially adverse psychosocial sequelae. Androgenetic alopecia (male pattern hair-loss) occurs in men with an inherited sensitivity to the effects of androgens on scalp hair. It is marked by visible loss of hair in areas of the scalp caused by progressive miniaturization of hair follicles.Currently, there are two FDA approved treatment options for AGA, topical minoxidil and oral finasteride. The exact mechanism of action of Minoxidil is uncertain, but it has been suggested that it promotes hair growth by opening adenosine triphosphate-sensitive potassium channels and stimulating the synthesis of vascular endothelial growth factor in dermal papilla cells. Despite of availability of treatment options, clinical trial data proving hair growth efficacy is limited. Therefore, the current investigator-initiated study is being conducted to understand the clinical efficacy of Minichek (Minoxidil 5%) in the treatment of androgenic alopecia. |