Health Condition 1: L65- Other nonscarring hair loss
Conditions
Interventions
Intervention1: Hair Care Serum: It is solution containing naturally available bioactive secondary metabolites.
5ml of Hair Care Serum is to be applied on the whole scalp each time, twice daily with 1
Sponsors
Vaishnavi Microbial Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects. 2. Subjects in the age group 18-60 years (both the ages inclusive). 3. Subjects suffering from excessive hair fall and/or dandruff as diagnosed by treating investigator. 4. Hair density of >100 and 5. Subjects falling under Grade 3 â?? 6 (Hamilton â?? Norwood Scale for Males) and Grade 1 â?? 3 (Ludwig Scale for Females) of hair loss severity. 6. Subjects on oral medications such as vitamin supplements, including multi-vitamins can also be included. 7. Subjects undergoing relevant treatment for Anemia (for hemoglobin correction) since the last two months can also be included. 8. Subjects undergoing relevant treatment for thyroid conditions since their initial diagnosis can also be included. 9. Subjects who have not participated in a similar investigation in the past three months. 10. Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration can be included. 11. Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
Exclusion criteria
Exclusion criteria: 1. Female Subjects who are known to be pregnant or breast feeding. 2. Subjects who are undergoing hair growth treatment within 3 months before screening into the study. 3. Subjects having any active scalp disease other than dandruff which may interfere in the study. 4. Subjects during screening visit diagnosed with Hemoglobin levels 5. Subjects during screening visit diagnosed with Thyroid disease to be excluded 6. Subjects who have treatments of cancer chemotherapy last 6 months before starting study or have a plan to do treatments of them during study terms. 7. Subjects who have history of trichotillomania. 8. Subjects who have had hair transplant. 9. Subjects who take pharmaceutical product which cause hirsutism. 10. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. 11. Subjects on oral medications which will compromise the study. 12. Chronic illness which may influence the cutaneous state. 13. Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, serious disorder of heart and respiratory apparatus or any other serious medical illness as established through medical history or diagnostic tests. 14. Subjects who could not be relied upon to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Mean changes in number of hair strands obtained by the comb test - Mean changes in Hair Density as observed using Trichoscan® - Mean changes in number of hair strands obtained by the hair pull testTimepoint: 15 days, 1stmonth, 2ndmonth, 3rdmonth, 4thmonth, 5thmonth and 6thmonth as compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in grade of Hamilton â?? Norwood Scale for Males and Ludwig Scale for Females of hair loss severityTimepoint: 15 days, 1stmonth, 2ndmonth, 3rdmonth, 4thmonth, 5thmonth and 6thmonth as compared to baseline;- Change in severity of dandruff as measured using Total Weighted Head Score Adhered Flakes (TWHS AF)Timepoint: 15 days, 1stmonth, 2ndmonth, 3rdmonth, 4thmonth, 5thmonth and 6thmonth as compared to baseline;- Mean change in density of Vellus and Terminal hairTimepoint: 15 days, 1stmonth, 2ndmonth, 3rdmonth, 4thmonth, 5thmonth and 6thmonth as compared to baseline;- Mean change in percentage of Anagen and Telogen hair (measured by Trichoscan®)Timepoint: 15 days, 1stmonth, 2ndmonth, 3rdmonth, 4thmonth, 5thmonth and 6thmonth as compared to baseline;- Number of adverse events (AE) or serious adverse events (SAE), either spontaneously reported by the subject, or noticed by the clinician will be recorded during the studyTimepoint: All visits;- Number of drop-outsTimepoint: All Visits;- Subject satisfaction with treatment as measured using self-reported questionnaire at end of treatmentTimepoint: at 6th month;- The safety in terms of vital signs of the subjectsTimepoint: All Visits | — |
Countries
India
Contacts
Public ContactDr M Guru Prasad
Vaishnavi Microbial Private Limited
Outcome results
None listed