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CTRI Number  CTRI/2026/03/105272 [Registered on: 03/03/2026] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   EFFICACY AND TOLERABILITY OF MICRONEEDLING ASSISTED TOPICAL O.O25% DUTASTERIDE LOTION MESOTHERAPY IN COMPARISION WITH MICRONEEDLING ALONE FOR TREATMENT OF ANDROGENETIC ALOPECIA IN MALES ON 5% MINOXIDIL LOTION-A randomised clinical study 
Scientific Title of Study   EFFICACY AND TOLERABILITY OF MICRONEEDLING ASSISTED TOPICAL O.O25% DUTASTERIDE LOTION MESOTHERAPY IN COMPARISION WITH MICRONEEDLING ALONE FOR TREATMENT OF ANDROGENETIC ALOPECIA IN MALES ON 5% MINOXIDIL LOTION-A randomised clinical study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Balkrishna Nikam  
Designation  MBBS MD DERMATOLOGY 
Affiliation  krishna vishwavidyapeeth karad  
Address  Nital skin clinic karad opposite to cottage hospital karad

Satara
MAHARASHTRA
415539
India 
Phone  8275061393  
Fax    
Email  mangeshnikam@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Balkrishna Nikam  
Designation  MBBS MD DERMATOLOGY 
Affiliation  krishna vishwavidyapeeth karad  
Address  Nital skin clinic karad opposite to cottage hospital karad

Satara
MAHARASHTRA
415539
India 
Phone  8275061393  
Fax    
Email  mangeshnikam@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Balkrishna Nikam  
Designation  MBBS MD DERMATOLOGY 
Affiliation  krishna vishwavidyapeeth karad  
Address  Nital skin clinic karad opposite to cottage hospital karad

Satara
MAHARASHTRA
415539
India 
Phone  8275061393  
Fax    
Email  mangeshnikam@yahoo.com  
 
Source of Monetary or Material Support  
krishan vishwa vidyapeeth karad 
 
Primary Sponsor  
Name  krishan vishwa vidyapeeth karad 
Address  krishna vishwa vidyapeeth karad 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
atharv deshmukh  krishna hospital karad  krishna vishwa vidyapeeth karad
Satara
MAHARASHTRA 
9881122769

atharvd517@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUE ETHICS COMITTEE KRISHNA VISHWA VIDYAPEETH KARAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Microneedling alone for androgenetic alopecia   microneedling procedure participants will receive Microneedling treatment from baseline followed by sessions every week for a total of 12 sessions. photographic and trioscopic evaluation will be done at every visit prilocaine with lidocaine (2.5 percent plus 2.5 percent) cream applied for 30 mins microneedling performed at dept of 1.5mm to with 12 pin needle 0.1mm bore adjusting for patient scalp thickness until pinpoint bleeding is observed  
Comparator Agent  Microneedling assisted topical 0.025 percent dutasteride lotion mesotherapy  microneedling procedure participants will receive Microneedling treatment from baseline followed by sessions every week for a total of 12 sessions. photographic and trioscopic evaluation will be done at every visit prilocaine with lidocaine (2.5 percent plus 2.5 percent) cream applied for 30 mins microneedling performed at dept of 1.5mm to with 12 pin needle 0.1mm bore adjusting for patient scalp thickness until pinpoint bleeding is observed application of topical 0.023percent dutasteride lotion 1 ml on treated scalp 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Age: Males aged 18 to 50 years.
2.Diagnosis of Androgenetic Alopecia: Male participants diagnosed with moderate to severe androgenetic alopecia (Norwood-Hamilton Grades 2-5).
Have given written consent before any treatment is commenced. 
 
ExclusionCriteria 
Details  1.Hypersensitivity to Dutasteride or Other 5-Alpha-Reductase Inhibitors: Participants with a known allergy or sensitivity to dutasteride or other similar medications (e.g., finasteride)..
2.Patient having keloid scaring or keloidal tendency.
3.History of bleeding disorder and anticoagulant therapy.
4.Oral steroid therapy.
5.Active skin infection like warts, herpes and bacterial infection.
6.Patient on any other systemic drugs therapy which in the judgement of investigator may interfere with interpretation of results.
7.Patients having any other inflammatory conditions of the scalp.
8.Hair loss due to any other etiology- malignancy or systemic illnesses.
Patients with known hypersensitivity to topical anaesthetic agents. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
increase in hair density from baseline to 6 months
increase in hair thickness from base line to 6 months 
increase in hair density from baseline to 6 months
increase in hair thickness from base line to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Hair Growth Rate: Change in hair growth rate (mm/month) from baseline to 6 months.
2. Anagen/Telogen Ratio: Change in anagen/telogen ratio from baseline to 6 months.
3. Patient-Reported Outcomes: Changes in patient-reported outcomes, such as hair growth satisfaction, hair loss severity, and quality of life. 
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   20/03/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ATHARVD517@GMAIL.COM].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-07-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Androgenetic alopecia (AGA), commonly known as male pattern baldness, is one of the most prevalent forms of hair loss affecting a significant proportion of males, particularly those over the age of 30. This condition can have a profound impact on a person’s self-esteem, social interactions, and overall quality of life. Despite the availability of treatment options such as minoxidil and finasteride, these therapies have limitations in terms of efficacy, side effects, and long-term sustainability.

Microneedling, a procedure involving the use of small needles to create controlled micro-injuries to the scalp, has gained attention as an effective treatment for AGA by promoting hair regrowth through collagen induction and enhancing the absorption of topical treatments. It has shown promise in improving hair density, regrowth, and scalp health when used either alone or in combination with other therapeutic agents.

On the other hand, dutasteride, a 5-alpha-reductase inhibitor, has proven effectiveness in the treatment of AGA by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone responsible for hair follicle miniaturization in AGA. While dutasteride is primarily used in oral form, recent studies suggest that topical applications of dutasteride may provide the same benefits with reduced systemic side effects, making it an appealing option for localized treatment.

Despite promising individual results with Microneedling and Application of Topical dutasteride, there is limited research on their combined use for treating AGA. Combining microneedling with dutasteride could theoretically amplify the beneficial effects of both treatments by increasing the absorption of dutasteride through the micro-channels created during the microneedling process and enhancing the regenerative effects of the treatment. This combination approach may also mitigate the limitations of each individual therapy, offering a safer and more effective alternative for patients with moderate to severe AGA.

 
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