A study to evaluate the Safety and Effectiveness of Tofacitinib Gel versus Minoxidil Solution in Treatment of Adult Male Patients with Androgenetic Alopecia.

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: L649- Androgenic alopecia, unspecified

• Registration Number: CTRI/2022/09/045412
• Lead Sponsor: MACLEODS PHARMACEUTICALS LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

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Study & Design

• Study Type: Interventional
• Study Design: Not specified