Health Condition 1: L648- Other androgenic alopecia
Conditions
Interventions
Intervention1: KeraScalp Hair Serum: Neat application, approx. 2 ml once daily when scalp and hair are dry for duration of 90 days.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
A Menarini India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 60 years (both inclusive) at the time of consent. 2) Sex: Healthy male or non-pregnant/non-lactating female. 3) Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening visit and Enrolment. 4) Subjects generally in good health. 5) Male subjects with Norwood Pattern II to IV of hair loss and female subjects with Ludwig Scale I to II of hair loss. 6) Subjects agreeing to undergo blood test for Hb and Thyroid to rule out any abnormalities which may affect treatment. 7) Subjects willing to refrain from any other treatment for the main indications for which the study test products are being given during the course of the study. 8) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair fall treatment/ hair products other than the test product for the entire duration of the study. 9) Subjects who have used other marketed product for hair fall control in the past. 10) Subject willing to use test product throughout the study period as instructed. 11) Subjects must be able to understand and provide written informed consent to participate in the study. 12) Subjects should be willing and able to follow the study protocol to participate in the study. 13) Subjects should be willing to allow to take photos of affected areas during the study duration.
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding or planning to become pregnant during the study period. 2) History of any dermatological condition of the scalp other than hair loss and/or dandruff. 3) History of prior use of scalp hair growth treatment within 3 months. 4) History of any prior hair growth procedures (e.g., hair transplant or laser). 5) Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study. 6) History of alcohol or drug addiction. 7) Subjects using other marketed hair fall control products during the study period. 8) Subjects who have plans of shaving of scalp hair during the course of the study. 9) Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 10) History or present condition of irritated or visibly inflamed scalp or severe scalp disease. 11) Subjects having a history or present condition of an allergic response to any cosmetic products or ingredient of study product. 12) Subjects with hair loss due to Autoimmune disorder/ Chemotherapy/ immunosuppressive drugs/ any major illness/ PCOS etc by history 13) Subjects participating in other similar cosmetic or therapeutic trial within last two weeks. 14) Any other condition which could warrant exclusion from the study, as per the Dermatologistââ?¬•s/investigatorââ?¬•s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of test product on anagen and telogen ratio by hair pluck test and microscopic evaluationTimepoint: baseline i.e Day 01, after treatment on Day 30, Day 90 and at end of follow up visit i.e. Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in general appearance of scalp skin i.e. itchiness, redness, roughness and scaliness of scalp by DermatologistTimepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit.;Physician and subject global aesthetic improvement scales (PGAIS and SGAIS)Timepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit.;Product PerceptionTimepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit.;Subject Satisfaction QuestionnaireTimepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit.;To assess the effect of test product in terms of change in general appearance of scalp hair i.e. Hair Volume (Full ââ?¬â?? Medium ââ?¬â?? Small) and Hair Density (Dense ââ?¬â?? Thinned/Shed) by DermatologistTimepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit.;To assess the effect of test product on Hair Fall Reduction by counting no. of hair break after 60 second combing methodTimepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit.;To assess the effect of test product on Hair thickness and Hair density by CASlite NovaTimepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit.;To assess the efficacy of the test product on Hair Strength by Hair Pull TestTimepoint: baseline on Day 01 and after treatment Day 30, Day 60 and Day 90 after application of test product and Day 120 at end of follow up visit. | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed