| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ATHARVD517@GMAIL.COM].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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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. |