Health Condition 1: L649- Androgenic alopecia, unspecified Health Condition 2: L639- Alopecia areata, unspecified
Conditions
Interventions
Intervention1: Oil shots: Mode of Usage: Apply one vial on the scalp every alternative night using the
dropper provided. Gently massage the scalp with fingertips for 3 5 minutes and
leave overnight
do not rinse.
Frequency: Daily overnight application
Rout of administration: Topical
Storage: Store in a cool and dry place away from direct sunlight and moisture
Control Intervention1: Nil: NA
Sponsors
Brillare Science Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18-55 years (both inclusive) for cohort A at the time of consent. 2) Age: 25-55 years (both inclusive) for cohort B at the time of consent. 3) Sex: Males and non-pregnant/non-lactating females. 4) Females of childbearing potential must have a self-reported negative urine pregnancy. 5) Participant is in good general health as determined by the Investigator on the basis of medical history. 6) Female with 40-50 counts and male with 25 -30 counts of hair fall at screening 7) Cohort B, participants with androgenic alopecia (Grade I or II) during clinical study and grade will be evaluated by the dermatologist trained evaluator by using Norwood-Hamilton classification and Ludwig pattern scale for female. 8) Participant is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. 9) If the participant is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 10) Participants are willing to give written informed consent and are willing to follow the study procedure. 11) Participants who commit not to use any other medicated/ prescription shampoos/hair care treatments, any other hair growth treatments or hair colour or dye, other than the test treatments for the entire duration of the study. 12) Willing to use test treatments throughout the study period. 13) Participant is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
Exclusion criteria
Exclusion criteria: 1) Participant have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems. 2) Participant have history of any dermatological condition of the scalp other than hair loss. . 3) Participant have history of any prior hair growth procedures (e.g. hair transplant or laser). 4) Participant who had taken topical treatment of hair loss for at least 4 weeks. 5) Participant who had taken any systemic treatment for at least 3 months. 6) History of alcohol or drug addiction. 7) Participant having history or present condition of an allergic response to any cosmetic treatments, any other condition which could warrant exclusion from the study. 8) Pregnant or breast feeding or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the effectiveness of the test treatments in Cohort A by assessing change in hair growth rate from tattoo area and in Cohort B by assessing change in hair growth rate from tattoo area and AGA affected area . 2.To assess the effectiveness of the test treatments in Cohort A by assessing change in hair thickness and hair density from tattoo area and in Cohort B by assessing change in hair thickness and hair density from tattoo area and AGA affected areaTimepoint: On 03 Days before Day 01, Day 01 and on Day 27( 2 Days) and Day 30 (03 Days from visit 04). From baseline before usage of the test treatments on Day 01 and after usage of the test treatments on Day 15 ( 2 Days), and Day 30 (03 Days from visit 04). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of the test treatments in terms of change in A:T ratioTimepoint: From baseline before usage of the test treatments on Day 01 and after usage of the test treatments on Day 30 (03 Days from visit 04).;2. To assess the effectiveness of the test treatments in terms of change in hair fall.Timepoint: From baseline before usage of the test treatments on Day 01 and after usage of the test treatments on Day 15 ( 2 Days), and Day 30 (03 Days from visit 04).;3. To assess the effectiveness of the test treatments in terms of change in general appearance of hair hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair oiliness, hair dryness and hair strength.Timepoint: From baseline before usage of the test treatments on Day 01 and after usage of the test treatments on Day 15 ( 2 Days), and Day 30 (03 Days from visit 04);4. To assess the effectiveness of the test treatments in terms of change in general appearance of scalp skin i.e. Itchiness, redness, roughness, and scaliness.Timepoint: From baseline before usage of the test treatments on Day 01 and after usage of the test treatments on Day 15 ( 2 Days), and Day 30 (03 Days from visit 04);5. To assess the effectiveness of the test treatments in terms of change in number of hairs Timepoint: From baseline before usage of test treatments on Day 01 and after usage of the test treatments on Day 30 (03 Days from visit 04).;6. To evaluate the effectiveness of the test treatment in terms of change in tensile strength of hair.Timepoint: From baseline before usage of the test treatments on Day 01 and after usage of the test treatments on Day 15 ( 2 Days), and Day 30 (03 Days from visit 04).;7. To evaluate the effectiveness of the test treatment in terms of change in hair strength.Timepoint: From baseline before usage of the test treatments on Day 01 and after usage of the test treatments on Day 15 ( 2 Days), and Day 30 (03 Days from visit 04).;8. To evaluate the effectiveness of th | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed