An Open Label, Prospective, Non-Comparative, Single Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of H-Vit Hair Serum of Systopic Laboratories Pvt. Ltd. in Hair Fall Control, Hair Growth Potential and Improvement in Hair Health in Adult Volunteers
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. 60 Second Hair Comb Test: Reduction of greater than or equal to 50 percent from Baseline
Study Overview
Brief Summary
Study Design : Open label, Prospective, Non Comparative NonRandomised, Single Arm Clinical Study
Indication : Hair Growth Potential, Hair Fall Control, HairHealth Parameters.
Investigational Product : H-Vit Hair Serum of SystopicLaboratories Pvt. Ltd.
Comparator: Not Applicable. Single Arm Non ComparativeStudy
Dose/Dosage: Product is provided in a 60ml bottle with aspray nozzle.Spray the product on the palm of one hand. Rub hands together tospread the product. Apply the product on hair from root to tip, spreadingevenly. Apply once a day at any time
Subject Population: Clinically Healthy adult subjects between theages of 21 and 55 years both ages and al genders inclusive looking to improvetheir hair health
Number of Subjects : 40Evaluable Subjects
**Treatment Arms:**1
**Treatment Duration:**90 Days
EfficacyAssessments 1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90 2. Visual Scalp Assessment Test : Day1.Day 45, Day 90 3. Hair Growth Questionnaire: Day 45,Day 90 4. Product Satisfaction Questionnaire: Day 90
Safety Assessment: Monitoring of the severity and frequency ofadverse events
Background of the study: Cosmetics specificallycosmeceuticals are becoming more high demand and in daily life. It is usedfrequently by many. Many use various products to enhance beauty and elegance tolook young. Cosmetics thus play a vital role in human life. Hair is one of theprimary part of the human body that adds beauty and also acts as a protectiveappendage. Hair Serum is a styling product that coats the surface of the hair. However, itis not just meant for styling. They could also treat multiple hair concernslike dry hair, dull hair and unmanageable hair. Hair serum can effectivelysmoothen, protect from environmental aggressors, reduce tangles, boostssmoothness all of which improves hair health, reduced the likelihood of excessivehair fall, thereby increasing hair growth potential.
Purpose of the Study : H-Vit Hair Serum by SystopicLaboratories is a cosmeceutical product that is designed with selectingredients specifically targeting the cosmetic aspects of a hair serum such asimprovement in hair shine, smoothness, detangler, protection from environmentalaggressor while also working towards reducing hair fall and improving hairgrowth potential thereby contributing to overall hair health. This clinicalstudy is done evaluate the safety and Tolerability of H-Vit Hair Serum ofSystopic Laboratories Pvt. Ltd in Hair Fall Control, Hair Growth Potential andimprovement in Hair health in adults.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 21.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Clinically healthy adult subjects between the ages of 21 and 55 years both ages and all genders inclusive looking to improve their hair health.
- •Subjects who agree not to dye or colour, cut or trim, straightening or other cosmetic treatments and or under go any hair treatments not limited to hair spa at beauty saloons or parlours for the duration of participation in the clinical study.
- •Subjects with complaints of non associated excessive hair fall, brittle or thin hair, dry or damaged hair.
- •Subjects who are willing to abstain from the use of any dedicated products not limited to hair oil, shampoo, conditioner, hair mask, hair serum, hair treatments and remedies to improve hair fall and other hair health parameters.
- •Subjects who are willing to abstain from the use of any oral or tropical medications not limited to collagen, biotin supplements indicated and improving hair fall and other hair health parameters.
- •Subjects who are willing to give informed consent for participation, able to comprehend ad understand the responsibilities during screening and treatment period
- •Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion Criteria
- •Subjects with known hypersensitivity to the ingredients of the investigational product.
- •Subjects who have had an active trichological procedure done upto 3 months prior to screening Subjects who have dyed their hair upto 30 days prior to screening
- •Subjects who have scalp conditions not limited to seborrheic dermatitis, psoriasis, alopecia areata, significant scalp scarring that prevents proper examination or evaluation of study criteria.
- •Subjects with Trichotillomania
- •Subjects who have anemia or iron deficiency.
- •Subjects who have previously undergone hair transplantation procedures.
- •Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying their responsibilities of the study.
- •Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •Subjects suffering from, on remission from cancer of any type less than 5 years at the time of screening.
- •Subjects who are planning a pregnancy and, or currently breastfeeding
- •Subjects who have participated in a clinical trial less than 1 month before screening.
- •Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse etc., any medical condition that unstable, poorly controlled or other factor e.g., planned relocation that the investigator felt would interfere with study evaluations and study participation.
- •Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol
- •Subjects who in the opinion of the investigator are not eligible for enrolment in the study.
Outcomes
Primary Outcomes
1. 60 Second Hair Comb Test: Reduction of greater than or equal to 50 percent from Baseline
Time Frame: 1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90 | 2. Visual Scalp Assessment : Day 1, Day 45, Day 90 | 3. Hair Growth Questionnaire : Day 45, Day90 | 4. Product Satisfaction Questionnaire : Day90
2. Visual Scalp Assessment: Increase of greater than or equal to 10 scores from base line
Time Frame: 1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90 | 2. Visual Scalp Assessment : Day 1, Day 45, Day 90 | 3. Hair Growth Questionnaire : Day 45, Day90 | 4. Product Satisfaction Questionnaire : Day90
3. Hair Growth Questionnaire: Total score lesser than or equal to 10 at end of study
Time Frame: 1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90 | 2. Visual Scalp Assessment : Day 1, Day 45, Day 90 | 3. Hair Growth Questionnaire : Day 45, Day90 | 4. Product Satisfaction Questionnaire : Day90
4. Product Satisfaction Questionnaire: Total score of greater than or equal to 5 at end of study
Time Frame: 1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90 | 2. Visual Scalp Assessment : Day 1, Day 45, Day 90 | 3. Hair Growth Questionnaire : Day 45, Day90 | 4. Product Satisfaction Questionnaire : Day90
Secondary Outcomes
- Not applicable(Not applicable)