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CTRI Number  CTRI/2022/09/045412 [Registered on: 12/09/2022] Trial Registered Prospectively
Last Modified On: 09/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the Safety and Effectiveness of Tofacitinib Gel versus Minoxidil Solution in Treatment of Adult Male Patients with Androgenetic Alopecia. 
Scientific Title of Study   A Prospective, Multi-center, Randomized, Open-label, Parallel-group, Active-Controlled Clinical Study to Compare the Efficacy and Safety of 2% w/w Tofacitinib Topical Gel (of Macleods Pharmaceuticals Ltd) versus 5% w/v Minoxidil Topical Solution in Treatment of Adult Male Patients with Androgenetic Alopecia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-035-TOFA-2021, Version no. 1.0, 30/Nov/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Mungantiwar 
Designation  Executive President - Medical Services, Head Clinical Trial 
Affiliation  Macleods Pharmaceuticals Ltd 
Address  Macleods Pharmaceuticals Ltd. R&D III Plot no 18,street no. 09, Marol, MIDC, Andheri (East) Mumbai (Suburban) MAHARASHTRA 400093 India

Mumbai (Suburban)
MAHARASHTRA
400093
India 
Phone  02248890100  
Fax  02229256229  
Email  drashish@macleodspharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Mungantiwar 
Designation  Executive President - Medical Services, Head Clinical Trial 
Affiliation  Macleods Pharmaceuticals Ltd 
Address  Macleods Pharmaceuticals Ltd. R&D III Plot no 18,street no. 09, Marol, MIDC, Andheri (East) Mumbai (Suburban) MAHARASHTRA 400093 India

Mumbai (Suburban)
MAHARASHTRA
400093
India 
Phone  02248890100  
Fax  02229256229  
Email  drashish@macleodspharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Mungantiwar 
Designation  Executive President - Medical Services, Head Clinical Trial 
Affiliation  Macleods Pharmaceuticals Ltd 
Address  Macleods Pharmaceuticals Ltd. R&D III Plot no 18,street no. 09, Marol, MIDC, Andheri (East) Mumbai (Suburban) MAHARASHTRA 400093 India

Mumbai (Suburban)
MAHARASHTRA
400093
India 
Phone  02248890100  
Fax  02229256229  
Email  drashish@macleodspharma.com  
 
Source of Monetary or Material Support  
MACLEODS PHARMACEUTICALS LTD 
 
Primary Sponsor  
Name  MACLEODS PHARMACEUTICALS LTD 
Address  Macleods Pharmaceuticals Ltd. R&D III Plot no 18,street no. 09, Marol, MIDC, Andheri (East) Mumbai (Suburban) MAHARASHTRA 400093 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr BS Chandrashekar  Cutis, Academy Of Cutaneous Sciences  Room no. 1, First Floor, 5/1, 4th Main Road, MRCR Layout, Vijayanagar, (Behind Godrej Interio, Near Veeresh Theatre), Bangalore - 560040
Bangalore
KARNATAKA 		 080-41159048

cutisclinic@gmail.com 
Dr Patnala Guru Prasad  King George Hospital  Room no. 2, First Floor, Department of dermatology, Maharanipeta, Visakhapatnam 530002
Visakhapatnam
ANDHRA PRADESH 		 891-2710839

drpguruprasadresearch@gmail.com 
Dr Shendkar Sonal Mahadev  Lifepoint Multispeciality Hospital  Room no. 1, 3rd floor, Clinical Research Department, 145/1, Mumbai Bangalore highway near Hotel sayaji Wakad Pune 411057
Pune
MAHARASHTRA 		 020-66434366

shendkar.sonal82@gmail.com 
Dr Manjunath Shenoy M  Omega Hospital  Room No. B-17, Basement, Mahaveer Circle, Kankanady, Mangalore, Karnataka, India - 575002
Dakshina Kannada
KARNATAKA 		 8242430000

manjunathshenoy.dermatology@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Cutis Institutional Ethics Committee - Dr. BS Chandrashekar  Approved 
Institutional Ethics committee, King George Hospital, Dr. Patnala G Prasad  Approved 
LPR Ethics Committee, Dr Shendkar Sonal   Approved 
Omega Ethics Committee, Dr. Manjunath Shenoy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Minoxidil topical solution  5% Minoxidil topical solution Apply to scalp twice daily for 16 weeks 
Intervention  Tofacitinib topical gel  2% Tofacitinib topical gel Apply to scalp twice daily for 16 weeks 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Men aged 30 to 60 years clinically diagnosed with androgenetic alopecia (male pattern hair loss)
2. Male subjects with a Norwood-Hamilton classified as II to IV
3. Subjects willing to follow and comply with same hair-care regimen (including hair style, hair color and length) during the treatment period
4. Sexually active male subjects must agree to use a barrier form of birth control during the study
5. Willing to provide written informed consent for the trial
 
 
ExclusionCriteria 
Details  A subject must not fulfil any exclusion criteria to participate in the study
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 efficacy or safety
5. Used hair weaving, hair extensions, texturizers, relaxers, occlusive wigs and non-study hair growth products or procedures within 30 days prior to screening
6. Subjects with following laboratory investigations results
• Hemoglobin less than 9 mg per dL
• Absolute neutrophil count (ANC) less than 1,000 per mm3
• Platelet count less than 50,000 per mL
• Serum prostate-specific antigen (PSA) level of more than 2.0 ng per mL
• Serum testosterone <250 ng per dL (evidence of hypogonadism)
• Positive serology test results or history for HIV, hepatitis B, or hepatitis C
• Serum TSH not within laboratory defined normal range
• Clinically significant deranged hepatic or renal laboratory parameters
• Clinically significant deranged cholesterol levels
• Blood creatine phosphokinase not within laboratory defined range
7. Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for 3 months prior to screening
8. History of thrombosis, including pulmonary, deep venous and arterial or gastrointestinal perforations, or history of chronic lung disease, interstitial lung disease
9. Have received prior medications procedures within the duration specified in the protocol
10. History of current or suspected systemic or cutaneous malignancy and or lymphoproliferative disease.
11. Current herpes zoster infection
12. Evidence of tuberculosis infection or history of incompletely treated or untreated tuberculosis.
13. 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 Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to enrollment into the study.
14. Participation in any other trial within 1 month prior to screening.
15. Subjects with clinical significant 12-lead ECG findings at screening as below:
• QTcF >450msec for males
• Heart rate < 45 or > 100 beats/minutes (inclusive)
• Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm
• Conduction disturbance including pulse rate more than 240 msec, pre-excitation (delta wave and pulse rate less than 120 msec), second or higher atrioventricular block
• Acute or chronic signs of ischemia
• Left bundle branch block
• History of myocardial infarction
• Any ECG abnormality which may, in the opinion of the investigator, may represent risk to the subject while participating in the study
16. Any clinically significant medical or surgical history or laboratory investigations
which in the opinion of the investigator may affect efficacy analyses of study
treatment or may impact subjects safety while participating in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage change in proportion of anagen hair using frontal, temporal and vertex trichoscopy in both the treatment groups (baseline to 16 weeks of treatment  baseline to 16 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients with increase in anagen hair using frontal temporal vertex trichscopy in both the treatment groups  baseline to 16 weeks of treatmentr  
 
Target Sample Size   Total Sample Size="236"
Sample Size from India="236" 
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   Phase 3 
Date of First Enrollment (India)   12/09/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a prospective, multi-center, randomized, open-label, parallel-group, active-controlled clinical study to compare the efficacy and safety of 2% w/w Tofacitinib topical gel versus 5% w/v Minoxidil topical solution in treatment of adult male patients clinically diagnosed with androgenetic alopecia. 
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