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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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