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CTRI Number  CTRI/2025/06/088918 [Registered on: 16/06/2025] Trial Registered Prospectively
Last Modified On: 16/06/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Effectiveness and Safety of Tugain F plus solution in Male baldness 
Scientific Title of Study   A Single Centre, Open Label Study to Evaluate Effectiveness and Safety of Minoxidil 5 percentage + Finasteride 0.1 percentage Solution Fortified with 0.0033 percentage Melatonin (Tugain F plus) in Males with Pattern Hair Loss 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS-CPI-002, Version 1.0, Dated 27 Jan 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B S Chandrashekar 
Designation  Chief Dermatologist and Managing Director 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Room No:1 Department of Dermatology
5/1,4th Main, MRCR Layout, Vijayanagar, Bnagalore
Bangalore
KARNATAKA
560040
India 
Phone  9740091155  
Fax    
Email  cacs0312@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B S Chandrashekar 
Designation  Chief Dermatologist and Managing Director 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Room No:1 Department of Dermatology
5/1,4th Main, MRCR Layout, Vijayanagar, Bnagalore

KARNATAKA
560040
India 
Phone  9740091155  
Fax    
Email  cacs0312@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B S Chandrashekar 
Designation  Chief Dermatologist and Managing Director 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Room No:1 Department of Dermatology
5/1,4th Main, MRCR Layout, Vijayanagar, Bnagalore

KARNATAKA
560040
India 
Phone  9740091155  
Fax    
Email  cacs0312@hotmail.com  
 
Source of Monetary or Material Support  
CUTIS Academy of Cutaneous Sciences 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore 560040 
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400013  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Riddhima Singh  CUTIS Academy of Cutaneous Sciences  Room No:1, Department of Dermatology 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore 560040
Bangalore
KARNATAKA 
8767995660

riddhima1702@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CUTIS Institutional Ethics Committee  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 
Comparator Agent  NA  NA 
Intervention  Tugain F+ solution: Minoxidil 5% + Finasteride 0.1% Solution Fortified with 0.0033% Melatonin  Apply to the scalp once daily for 12 weeks. 1 ml per application approximately 5 sprays 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Male 
Details  1.Male aged 18 to 49 years clinically diagnosed with androgenetic alopecia (male pattern hair loss).
2.Male subjects with Norwood-Hamilton grades II to V.
3.Subjects willing to follow and comply with the same hair-care regimen (including hair style, hair color and length) during the treatment period.
4.Willing to provide written informed consent for the trial. 
 
ExclusionCriteria 
Details  1.Known hypersensitivity to study treatment and its ingredients.
2.Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia.
3.Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
4.Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of effectiveness or safety.
5.Used hair weaving, hair extensions, texturizers, relaxers, occlusive wigs and non- study hair growth products (oral or topical) from prescription or over the counter /procedures within 30 days prior to screening.
6.Have received prior medications procedures within 30 days prior to screening.
7.History of current or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease.
8.Evidence of tuberculosis infection or history of incompletely treated or untreated tuberculosis.
9.History of serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to screening.
10. Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to the enrolment into the study.
11.Participation in any other trial within 1 month prior to the screening.
Any clinically significant medical or surgical history or laboratory investigations which in the opinion of the investigator may affect effectiveness analyses of study treatment or may impact the subject’s safety while participating in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment   Baseline to 12 weeks of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Percentage change in the proportion of general hair count, general hair density, anagen %, telogen %, terminal %, vellus %, mean hair thickness and total follicular units at frontal, temporal and vertex region using trichoscopy  Baseline to 12 weeks of treatment 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   30/06/2025 
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 Yet Recruiting 
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 - NO
Brief Summary  

Male pattern hair loss (MPHL) is the most common hair loss disorder in men, also known as androgenetic alopecia (AGA) due to the unclear link with androgens. It is characterized by progressive thinning in the central, frontal, and parietal scalp regions. It’s a non-scarring condition resulting from hair follicle miniaturization (Fabbrocini et al., 2018). Baldness affects both men and women, though it is more commonly seen in men. MPHL accounts for 58% of diffuse hair loss aged 30–50 years among Indian men (Mysore et al., 2019).

Etiology and Pathogenesis

MPHL is a multifactorial condition primarily influenced by genetic predisposition and hormonal factors. Its pathogenesis involves the action of androgens, particularly dihydrotestosterone (DHT), which induces hair follicle miniaturization and alters the hair growth cycle. A comprehensive understanding of MPHL requires exploring genetic determinants, hormonal impacts, and cellular mechanisms. 

Genetic Factors 

MPHL is highly heritable, with recent studies identifying 389 genomic regions associated with the condition. Key genes implicated in MPHL are those involved in androgen signaling and hair follicle development, underscoring the genetic basis of the disorder (Henne et al., 2023). 

Hormonal Influence 

Androgens play a pivotal role in MPHL, particularly in the miniaturization of hair follicles within the frontal and vertex regions of the scalp (P et al., 2024; Goodarzi et al., 2009). The condition typically manifests during puberty, with as many as 80% of men experiencing some degree of hair loss over their lifetime (Henne et al., 2023). 

Cellular Mechanisms 

At the cellular level, MPHL involves a dysregulation of the hair growth cycle, marked by a shortened anagen phase and a prolonged kenogen phase, leading to progressively thinner hair (Redmond et al., 2023). Emerging evidence also points to the role of microRNAs in hair follicle biology, highlighting their potential involvement in the condition’s pathophysiology (Goodarzi et al., 2010). 

While genetic and hormonal factors remain central to MPHL, growing evidence suggests that environmental and lifestyle factors, including smoking and stress, may contribute to its progression (P et al., 2024). Understanding these multifactorial influences is essential for developing targeted therapeutic approaches. 

Cipla Ltd has developed a medication Tugain F+ for controlling Androgenetic alopecia. The product consists of Minoxidil 5% + Finasteride 0.1% Solution Fortified with 0.0033% Melatonin. Currently, there are only two US Food and Drug Administration (FDA)-approved drugs for AGA: topical minoxidil and oral finasteride.

The combination of minoxidil and finasteride is well-supported by clinical evidence, the role of melatonin remains less established (Chandrashekar et al., 2015; Husanain et al., 2021; Fischer et al 2004). This study seeks to provide insights into effectiveness of combination minoxidil, finasteride with melatonin, outcome of the treatment and also documenting the safety profile of this combination.

 
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