Health Condition 1: L659- Nonscarring hair loss, unspecified
Conditions
Interventions
Intervention1: Tugain Eva: Minoxidil 5% solution fortified with 0.0033% melatonin: Apply to the scalp once daily for 12 weeks. 1 ml per application approximately 5 sprays.
Control Intervention1: Tugai
approximately 5 sprays
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female aged 18 to 55 years clinically diagnosed with androgenetic alopecia (female pattern hair loss). 2.Female subjects with Sinclair scale II to III. 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, hypo/hypertension or medical therapy. Pregnancy and lactation, planning pregnancy will be excluded from the study. 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 (oral or topical) from prescription or over the counter /procedures within 30 days during screening. 6.Have received prior medications/procedures within 1 month duration specified in the protocol. 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 Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to the enrolment into the study. 10.Participation in any other trial within 1 month during the screening. 11.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 the subject’s safety while participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hair count, hair density, Anagen/ Telogen ratio, terminal hair, vellus hair, mean thickness, total follicular units at frontal, temporal and vertex areas of the scalp in both the treatment groups (baseline to 12 weeks of treatment).Timepoint: After 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| •Change in hair count, hair density, Anagen/ Telogen ratio, terminal hair, vellus hair, mean thickness, total follicular units at frontal, temporal and vertex areas of the scalp in both the treatment groups (baseline to 12 weeks of treatment). •Development of new hair growth/scalp coverage as assessed by the investigator using a five-point rating scale based on global scalp photographs in both treatment groups (baseline to 12 weeks of treatment). •Subject self-satisfaction assessment based on five-point rating scale in both treatment groups (baseline to 12 weeks of treatment).Timepoint: After 3 months | — |
Countries
India
Contacts
Public ContactDr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences
Outcome results
None listed