Status:
COMPLETED
A Clinical Study to Assess the Safety and Effectiveness of Plant-based Biotin and Plant Based Biotin with Silica in Healthy Human Subjects with Complaints of Hair Fall, Thin, Dry, & Brittle Hair, and Dry Skin
Lead Sponsor:
NovoBliss Research Pvt Ltd
Collaborating Sponsors:
Orgenetics, Inc.
Conditions:
Hair Falling
Thin Hair
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with complaints of hair f...
Detailed Description
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Total study visits will be 8 during this study. Vis...
Eligibility Criteria
Inclusion
- Age: 20 to 60 years (both inclusive) at the time of consent
- Sex: Healthy males and non-pregnant/non-lactating females.
- Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
- Females of childbearing potential must have a reported negative pregnancy test.
- Subject are generally in good health.
- Subject must have negative Hepatitis B Surface Antigen Test at baseline.
- Subject with self-proclaimed nonpathological thin, dry and brittle hair.
- Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
- Subject 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.
- Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
- If the subject 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.
- If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
- Subjects are willing to give written informed consent and are willing to follow the study procedure.
- Subjects who have used other marketed products for hair thinning in the past.
- Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test treatments for the entire duration of the study.
- Willing to use test treatments throughout the study period.
Exclusion
- Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
- Subject has a history of allergy or sensitivity to the test treatment ingredients.
- Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
- Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- Subject is currently pregnant/breastfeeding.
- Subject has a history of prior use of hair growth treatment within 3 months.
- Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
- Subject has a history of alcohol or drug addiction.
- Subjects who have plans of shaving scalp hair during the study.
- Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- History of chronic illness which may influence the cutaneous state.
- Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or hair/scalp/skin care products within the last four weeks.
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05972512
Start Date
August 22 2023
End Date
December 14 2023
Last Update
March 3 2025
Active Locations (1)
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1
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India, 382421