| 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
|
|
|
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
|
|
|
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. |