Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: 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
Co
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatmentTimepoint: Baseline to 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 trichoscopyTimepoint: Baseline to 12 weeks of treatment | — |
Countries
India
Contacts
Public ContactDr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences
Outcome results
None listed