Health Condition 1: null- Androgenetic Alopecia
Conditions
Interventions
Intervention1: Alpecin: Alpecin liquid is a topical solution for management of alopecia. It is commercially available in the form of solution in 200 mL bottles. It is manufactured by Dr Kurt Wolff Gmb
Sponsors
Fullife Healthcare Pvt Ltd
JSS Medical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males aged between 18-55 years 2. Balding stage of III-V on the Hamilton scale and use of global photography to confirm the Hamilton-Norwood stage of balding 3. At least 20% telogen ratio in trichogram 4. Willingness to participate and signing the informed consent form
Exclusion criteria
Exclusion criteria: 1. Diagnosed with pathologic forms of alopecia like alopecia areata, trichotillomania, scarring alopecia, drug based alopecia 2. Diagnosed with dermatologic conditions like eczema, fungal scalp infections, seborrheic dermatitis, recurrent herpes, pityriasis versicolor, psoriasis, pigmentary disorders (vitiligo, chloasma), chronic lupus erythematous 3. History of chemotherapy 4. Known hypersensitivity to Mx-5 or any excipients of Alpecin that could interfere directly/indirectly with the study 5. Use of any anti-hair loss treatment within the last 6 months prior to the screening visit 6. Participation in another trial of an investigational product within 28 days prior to the screening visit 7. Any other clinically significant medical condition e.g. active infections, cardiac, psychiatric, neurological, pulmonary, immunological conditions, or hypertension etc. which may, in the judgment of the investigator, interfere with the subjectâ??s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in anagen rate (AR) (%) from baseline to 6 months (EOS) using frontal and occipital trichogram.Timepoint: from baseline to 6 months (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in AR (%) from baseline to 3 months and to 6 months (EOS) using frontal and occipital trichogram, separatelyTimepoint: from baseline to 3 months and to 6 months (EOS);â?¢ Change in clinical effect as assessed by dermatologist questionnaire from baseline to 3 months and to 6 months (EOS)Timepoint: from baseline to 3 months and to 6 months (EOS);â?¢ Change in subjectâ??s perception of effect of Alpecin with Mx-5 in terms of hair loss management as assessed by subject questionnaire from baseline to 3 months and to 6 months (EOS)Timepoint: from baseline to 3 months and to 6 months (EOS);â?¢ Incidence of adverse events (AEs) during the studyTimepoint: during the study period;â?¢ Number of subjects with increase in anagen hair (and decrease in telogen hair) using frontal trichogram from baseline to 3 months and to 6 months (EOS)Timepoint: from baseline to 3 months and to 6 months (EOS);â?¢ Number of subjects with increase in anagen hair (and decrease in telogen hair) using occipital trichogram from baseline to 3 months and to 6 months (EOS)Timepoint: from baseline to 3 months and to 6 months (EOS);â?¢ Change in vital signs from baseline to 6 months (EOS)Timepoint: from baseline to 6 months (EOS) | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed