To Evaluate Efficacy and Safety of KeraScalp Hair Serum in subjects with Mild to Moderate Alopecia of Scalp.

Completed

Conditions: Other androgenic alopecia,

Registration Number: CTRI/2022/02/040485

Lead Sponsor: A Menarini India Private Limited

Brief Summary: This is an open label,single-arm, clinical study to evaluate efficacy and safety of KeraScalp Hair Serum in subjects with Mildto Moderate Alopecia.

The potential subjects will bescreened as per the inclusion and exclusion criteria only after obtainingwritten informed consent from the subjects.

There are total 10 visits inthe study i.e.

Â·     Visit 01: ScreeningVisit (07 days prior to Day 01)

Â·     Visit 02: For Shavingof Test Area (03 days prior to Day 01)

Â·     Visit 03: EnrolmentVisit â€“ Baseline Assessment i.e., Day 01

Â·     Visit 04: For Shavingof Test Area i.e., Day 27 (Â± 2 Days) (03 days prior to Day 30)

Â·     Visit 05: TreatmentPhase i.e., Day 30 (+ 2 Days)

Â·     Visit 06: TreatmentPhase i.e., Day 60 (Â± 2 Days)

Â·     Visit 07: For Shavingof Test Area i.e., Day 87 (Â± 2 Days) (03 days prior to Day 90)

Â·     Visit 08: TreatmentPhase i.e., Day 90 (+ 2 Days) , End of Treatment Phase (EOT)

Â·     Visit 09: Follow upperiod i.e., Day 117 (Â± 2 Days) (03 days prior to Day 120)

Â·     Visit 10: Follow up period i.e., Day 120 (+ 2 Days) , Endof Study (EOS)

Procedure for Test Product use: Hair serum to be applied when the hair & scalp are completely dry. **Approx.** **2 ml of hair serum to be used oncedaily.** Apply serum on the affected area by gentlemessaging with the fingertips. Subjects should ensure that they wash their handswith soap after applying hair serum.

Before entering thefacility, at security check-post, subjects will be asked for pre-entry scrutinycheck for COVID-19 symptoms. Study can be conducted in multiple batches (set ofsubjects) in order to follow the norms of covid-19 restrictions.

Instrumental assessment, dermatological assessmentsand questionnaires for hair will be assessed. Digital Photographs will betaken. Safety will be assessed throughout the study by monitoring of adverseevents.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

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.
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

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.
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 Dermatologistâ€™s/investigatorâ€™s discretion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of test product on anagen and telogen ratio by hair pluck test and microscopic evaluation	baseline i.e Day 01, after treatment on Day 30, Day 90 and at end of follow up visit i.e. Day 120

Secondary Outcome Measures

Name	Time	Method
To assess the effect of test product on Hair thickness and Hair density by CASlite Nova	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 method	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 Test	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 â€“ Medium â€“ Small) and Hair Density (Dense â€“ Thinned/Shed) by Dermatologist	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.
Change in general appearance of scalp skin i.e. itchiness, redness, roughness and scaliness of scalp by Dermatologist	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 Perception	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 Questionnaire	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)	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.

Trial Locations

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Joshi
Principal investigator
8000085049
pjoshi@ofacto.com