A Proof-Of-Concept, Safety and Efficacy study of Hair Fall Control Oil Shots to Evaluate Reduction in Hair Fall in Healthy Adult Human Subjects with Hair Fall
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Mean percentage change in hair fall reduction
Study Overview
Brief Summary
The rationale of the study is to evaluate the health claims of this hair fall control oil shot which is a mixture of multiple herbal oils which are well known traditionally to improve hair fall by strengthening and nourishing the hair roots and improving hair and scalp health. Each oil is useful to treat hair and scalp related diseases. This clinical study is to investigate the proof of science/concept, safety and efficacy of Hair Fall Control Oil shots to improve hair fall in healthy adult human subjects with hair fall complaints. The study would demonstrate that continuous care of hair and scalp with regular usage of test Hair fall control oil shot throughout the hair growth life cycle would help in reducing hair fall. This is an open-label, single-arm, single-centre, proof-of-concept, safety and efficacy, a clinical study of a Hair Fall Control Oil Shots in hair fall reduction in 18 to 65 years old healthy adult human subjects with hair fall after consecutive 2-weeks of usage. Total 8 oil shots will be applied by the subjects in 15 days (2 weeks) on every alternative day. The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining a written informed consent form from the subjects before doing any evaluations. There will be 03 visits during the conduct of the study. The duration of the study will be 15 days with +2 days window period from enrolment.
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Visit 01 (Day 01): Screening, Enrolment, 60seconds Hair Combing test, other evaluations before product application
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Visit 02 (Day 02): 60seconds Hair Combing test [1st wash at NovoBliss Site - After Single Shot application
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Visit 03 (Day 16): Evaluation Visit, End of study [Week 2]
During this clinical study, each study activity will be performed per standardized method established at/By NovoBliss Research during an in-house Validation study to have maximum consistency and minimal inter-observer and inter-operator variability.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age: 18 to 65 years (both inclusive) at the time of consent.
- •Sex:Â Healthy males and non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subjects are generally in good health.
- •Females with 40-50 counts and males with 25-30 counts of hair fall from the hair combing method (60-sec hair count) at the screening visit 1 before product application.
- •Â All hair colours except grey hair.
- •Subjects with self-proclaimed nonpathological thinning of hair.
- •Â 10)Subjects willing to give written informed consent and willing to follow study procedure.
- •Subjects who have used other marketed products for hair fall control in past.
- •Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair growth, hair fall treatment, hair products other than the test product for the entire duration of the study.
- •Willing to use test product throughout the study period.
Exclusion Criteria
- •Subjects with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.
- •Â History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •Â History of prior use of scalp hair growth treatment within 3 months.
- •Â History of any prior hair growth procedures (e.g., hair transplant or laser).
- •Â Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •History of alcohol or drug addiction.
- •Â Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •Â Subjects who have plans of shaving of scalp hair during the study.
- •Â Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •Â History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Â Subjects having a history or present condition of an allergic response to any cosmetic products.
- •Â Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Â Pregnant or breastfeeding or planning to become pregnant during the study period.
- •Â Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks.
Outcomes
Primary Outcomes
Mean percentage change in hair fall reduction
Time Frame: Baseline on Day 1 before application to Day 02 (1st Wash) and on Day 15 after applications
Secondary Outcomes
- To assess the effect of the test product in terms of Scalp Hydration using MoistureMeterEpidD instrument(Baseline on Day 1 before application to Day 15 after applications)
- To assess the effect of test product in terms of change in the general appearance of hair --- Hair Volume, Hair Density, Hair Plasticity, Hair smoothness, Hair Oiliness, Shininess after 15 Days (2 weeks) of application Evaluated by the Dermatologist Trained Evaluator | Dermatologist.(Baseline on Day 1 before application to Day 15 after applications)
- To assess the effect of the test product in terms of Scalp Appearance  --- itchiness, redness, roughness, and scaliness of scalp after 15 days (2 weeks) of application evaluated by the Dermatologist Trained Evaluator | Dermatologist(Baseline on Day 1 before application to Day 15 after applications)
- To assess the effect of the test product in terms of hair strength -- poor, average, good evaluated by the Dermatologist Trained Evaluator | Dermatologist(Baseline on Day 1 before application to Day 15 after applications)
- To assess the effect of test product in terms of product perception after 15 Days of product applications using the subjective perception questionnaires about the product(Baseline on Day 01 before application to Day 15 after applications)