None listed
Conditions
Interventions
Intervention1: Romantaque Lotion: FDA approved cosmetic product for sale in India.
Dose daily topical application for 15 days after hair removal by waxing for three consecutive hair growth cycles.
Con
Sponsors
Mrs Mrinmayee Bhushan Kondhalkar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject did not have any known illness, infection 2.Subject did not have any Known allergy/ sensitivity 3.Clinically Healthy subject
Exclusion criteria
Exclusion criteria: 1. Patients Having Known Skin diseases 2.Patients of age below 18 years and above 60 years were excluded from study. 3.Pregnant women and planning to be pregnant within six months were excluded from study. 4.Lactating Mother 5.Malignant and accelerated hypertensive 6.Patient undergoing regular treatment for Diabetes or for any other severe illness 7.Patients who had not signed Informed Consent form. 8.Any condition that, in the opinion of the investigator, did not justify the patientsâ?? inclusion for the study. 9.Gender Male
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Protocol- RMTK01- Safety was evaluated by reporting adverse events or severe adverse events, if any (Ref: IS 4011:1997/2009) Protocol- RMTK02- Use Test- Hair growth inhibition was evaluated by using trichogram Timepoint: Protocol- RMTK01-Time point: 7 days Protocol- RMTK02-Time point: 120 days (40, 80 and 120th day) | — |
Primary
| Measure | Time frame |
|---|---|
| Protocol- RMTK01- Draize test- Safety was evaluated by using Draize test score (Ref: IS 4011:1997/2009) Protocol- RMTK02- Use Test- Safety was evaluated by using Use test (Ref: IS 4011:1997/2009) Timepoint: Protocol- RMTK01- Draize test- Time point: 48 hours Protocol- RMTK02- Use Test- Time point: 15 days | — |
Countries
India
Contacts
Public ContactMrs Mrinmayee Bhushan Kondhalkar
APT Research Foundation
Outcome results
None listed