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

Last updated: February 27, 2025
Sponsor: NovoBliss Research Pvt Ltd
Overall Status: Completed

Phase

N/A

Condition

Alopecia

Hair Loss

Treatment

Botanical extract of standardized biotin

Placebo

Botanical extract of standardised biotin with silica

Clinical Study ID

NCT05972512
NB230019-OI
  • Ages 20-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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 fall, thin, dry, and brittle hair, and dry skin.

A sufficient number (maximum of 105 (35 subject/test treatment)) of female/male adult subjects will be recruited/enrolled to ensure a total of 96 subjects (32 subjects/test treatment) complete the study.

Eligibility Criteria

Inclusion

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 theduration of the study.

  9. Subject is able to remain on stable doses of contraceptive or replacement hormonaltherapy, 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 fromintroducing any new skin care products during the study.

  11. Subject is able to forgo changes in baseline medications and nutritional supplementsduring the study period.

  12. If the subject is of childbearing potential, is practicing and agrees to maintain anestablished method of birth control (IUD, hormonal implant device/injection, regularuse of birth control pills or patch, diaphragm, condoms with spermicide or spongewith spermicidal jelly, cream or foam, partner vasectomy or abstinence). Femaleswill 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 contraceptionfor at least 6 months and agrees to continue using the same contraception for theduration 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 thestudy 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, treatmentfor thin hair, or hair products other than the test treatments for the entireduration of the study.

  18. Willing to use test treatments throughout the study period.

Exclusion

Exclusion Criteria:

  1. Subjects with a history of hair thinning/hair fall due to any clinically significantself-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 hairloss and/or dandruff or active dermatological condition that might interfere withthe 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 touse at any point during the study.

  5. Subject has applied any topical retinoids within 2 weeks of the screening visit oranticipates having to use at any point during the study.

  6. Subject is not willing to avoid unprotected sun or other UV radiation exposureduring 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 orlaser).

  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 orsevere scalp disease.

  13. Any other condition which could warrant exclusion from the study, as per thedermatologist'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 ortherapeutic trials or hair/scalp/skin care products within the last four weeks.

Study Design

Total Participants: 105
Treatment Group(s): 3
Primary Treatment: Botanical extract of standardized biotin
Phase:
Study Start date:
August 22, 2023
Estimated Completion Date:
December 14, 2023

Study 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.

Visit 01 (Within 30 Days): Screening procedure, Informed consent obtain process, baseline evaluations, blood collection, tattoo on scalp, hair growth rate measurement Visit 02 (Day 01): Enrolments, hair growth rate measurement, other evaluations, product distribution, diary distribution, AE reporting (if any.

Visit 03 (Day 27 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE reporting (if any).

Visit 04 (3 Days from Visit 03): Treatment period, evaluations, diary card review, AE Reporting (if any).

Visit 05 (Day 57 + 2Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any).

Visit 06 (3 Days from Visit 05): Treatment period, evaluations, diary card review, AE Reporting (if any).

Visit 07 (Day 87 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any).

Visit 08 (3 days from Visit 08): Evaluations, dairy card collection, AE reporting, test treatments accountability, End of Study process.

done on Day 04 before Day 01, Day 01 and after test treatment usage will be done on Day 27, Day 30, Day 57, Day 60, Day 87, Day 90 as listed-below.

  • 60-S Hair Combing Method: Hair Fall.

  • CASALite Nova (Phototrichogram): Hair Density, Thickness, Hair Growth Rate, Scalp Condition.

  • PGA Score: Signs of brittle nails, surface roughness, raggedness and peeling.

  • Visioscan®VC 20plus (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness (Right cheek).

  • MoitureMeterEPiD: Skin hydration (Right cheek).

  • Hair Pull Test: Hair strength.

  • Pluck Test: A:T ratio (Hair Growth Cycle)

  • Cutometer: Skin elasticity (Right cheek).

  • PGA Griffith Scale: Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness

  • Tewameter® TM 300: Skin barrier function (Right Cheek)

  • General Appearance of Hair: Hair shininess, hair reflection, hair plasticity, hair fizziness, hair volume, hair density Digital photographs: Facial photographs before test treatment consumption and after test treatment consumption

  • Blood parameters: CBC, total Serum Cholesterol, Triglyceride, Random Glucose, LDL, HDL [Note: blood collection will be performed on Day 01 And Day 90]

  • Blood parameter: HBsAg (Hepatitis B surface antigen) - Screening only

  • Subjective product perception assessment regarding the test treatment's effect on skin elasticity, suppleness, skin color, fragrance, taste, skin hydration, skin tone, firmness, appearance, hair and nails, strongness and shine.

Connect with a study center

  • NovoBliss Research Pvt Ltd

    Gandhinagar, Gujarat 382421
    India

    Site Not Available

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