Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: PDFE-2304: Bimatoprost 1 percent and Levocetirizine 1 percent Topical Solution of 1 ml over the scalp using a dropper twice a day for 112 days
Control Intervention1: Minoxidil 5 percent
Sponsors
Dr Shivaprasad Kumbar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men who have a presentation of androgenetic alopecia (Norwood II - V). 2. Age between 18 to 60 years of age (both inclusive). 3. Have no abnormal findings during physical examination. 4. Able to comply with the study procedures in the opinion of the PI/CI. 5. Able to give written consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or idiosyncratic reaction to study formulation. 2. Clinical diagnosis of non-AGA forms of alopecia. 3. History of hair transplants. 4. Subject having dyed or bleached hair 12 months prior to study start. 5. Use of any topical product in the target region in the last 6 months. 6. A medical history of receiving chemotherapy/cytotoxic agents. 7. Uncontrolled hypertension. 8. Any dermatological disorders (eczema, psoriasis, sun damage, skin cancer). 9. Hormonal diseases such as thyroid disorders or diabetes. 10. Liver and kidney disease. 11. Smokers. 12. Drug or alcohol abuse within 12 months. 13. No written consent. 14. The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the treatment in target area hair count (by dermatoscope photo).Timepoint: Baseline, Week 16 (Day 112) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Day 56 target area hair count (by dermatoscope photo)Timepoint: Baseline, Week 8 (Day 56);Comparison of Subject Self-Assessment in Alopecia (SSA) Score between test product and comparator.Timepoint: Week 16 (Day 112);Target Area Hair Width (from overview photo), Target Area Hair Darkness (from overview photo)Timepoint: Week 16 (Day 112);Comparison of Investigator Global Assessment (IGA) Score between test product and comparator.Timepoint: Week 16 (Day 112);Global Panel Review (from overview photo)Timepoint: Week 16 (Day 112);Subject health, well-being & vitals (Blood pressure, radial pulse, respiratory rate and body temperature) will be monitored and assessed at all visitsTimepoint: Day 1, Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84) & Week 16 (Day 112) | — |
Countries
India
Contacts
Public ContactDr T Vijayakumara Adavi
Koppal Institute of Medical Sciences
Outcome results
None listed