None listed
Conditions
Interventions
Intervention1: Hair Serum: Hair serum 1ml not exceeding 2ml to be applied topically by gentle massage on the scalp twice daily (morning & night) for a period of 90 days.
Control Intervention1: NIL: NI
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female healthy adult subjects ranging in age from 18 to 65 years both inclusive. 2 Willingness to follow the protocol requirements as evidenced by written informed consent. 3 Agree not to use any medication, including vitamins and minerals during or before the course of this study. 4 Mild to moderate hair loss classified as the Norwood-Hamilton type II,III,IV and V in males and Ludwig type I and II in females. 5 Willing to come for all follow-up visits.
Exclusion criteria
Exclusion criteria: 1 Any clinically significant medical history, medical finding or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. 2 On any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement. 3 History of hypersensitivity reactions. 4 Participation in a clinical study during the preceding 90 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Subject Self Assessment Questionnaire 2 Visual Analog Scale 3 60 Second Hair Comb test 4 Hair Pull Test 5 Clinical photographs of the vertex and superior frontal scalp 6 Investigator Assessment Scale 7 Hair Analysis by Trichoscan Hair density, hair diameter, hair growth rate, or anagen/telogen ratioTimepoint: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) 2 VAS(Screening,Day30,Day60 & Day90) 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) 4 Hair Pull Test(Screening,Day30,Day60 & Day90) 5 Clinical photographs(Screening & Day90) 6 Investigator Assessment Scale(Day90) 7 Trichosan Analysis(Screening & Day90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse EventsTimepoint: 1 Adverse Events (Visit 3, Visit 4, Visit 5 and via telephonic follow up to 15 days after Day 90). | — |
Countries
India
Contacts
Public ContactMr Hasan Ahmed
ClinWorld Private Limited
Outcome results
None listed