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

Launched by NOVOBLISS RESEARCH PVT LTD · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of plant-based biotin, both alone and combined with silica, for people experiencing hair issues like hair fall, thin hair, dry and brittle hair, as well as dry skin. The study will involve healthy adults aged 20 to 60 who have these hair and skin concerns. To participate, individuals must be in good health, not pregnant or breastfeeding, and willing to avoid certain hair treatments and cosmetic products during the study.

Participants can expect to be randomly assigned to one of three groups: one receiving plant-based biotin, one receiving biotin with silica, and one receiving a placebo (a non-active treatment). Over the course of the study, they will follow their regular skincare routines without introducing new products. The study aims to recruit a total of 96 participants, and those who enroll will help researchers understand how effective these plant-based treatments are for improving hair and skin conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 20 to 60 years (both inclusive) at the time of consent
• • 2. Sex: Healthy males and non-pregnant/non-lactating females.
• • 3. Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
• • 4. Females of childbearing potential must have a reported negative pregnancy test.
• • 5. Subject are generally in good health.
• • 6. Subject must have negative Hepatitis B Surface Antigen Test at baseline.
• • 7. Subject with self-proclaimed nonpathological thin, dry and brittle hair.
• • 8. Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
• • 9. 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.
• • 10. Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
• • 11. Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
• • 12. 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.
• • 13. 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.
• • 14. Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
• • 15. Subjects are willing to give written informed consent and are willing to follow the study procedure.
• • 16. Subjects who have used other marketed products for hair thinning in the past.
• • 17. 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.
• • 18. Willing to use test treatments throughout the study period.
• Exclusion Criteria:
• • 1. Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
• • 2. Subject has a history of allergy or sensitivity to the test treatment ingredients.
• • 3. 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.).
• • 4. 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.
• • 5. Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
• • 6. Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
• • 7. Subject is currently pregnant/breastfeeding.
• • 8. Subject has a history of prior use of hair growth treatment within 3 months.
• • 9. Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
• • 10. Subject has a history of alcohol or drug addiction.
• • 11. Subjects who have plans of shaving scalp hair during the study.
• • 12. Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
• • 13. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
• • 14. Pregnant or breastfeeding or planning to become pregnant during the study period.
• • 15. History of chronic illness which may influence the cutaneous state.
• • 16. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or hair/scalp/skin care products within the last four weeks.