Clinical trial NCT05800496: A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Subjects With Thin, Dry, and Brittle Hair
Official title: A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin in Healthy Adult Human Subjects With Thin, Dry, and Brittle Hair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Thinning
Hair Brittle
Dry Hair
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: ZYWIE VENTURES PRIVATE LIMITED
First posted: 2023-04-05
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry, and brittle hair.

a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.

Detailed description: This is a randomised, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry and brittle hair.

a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.

total of 51 subjects was completed the study. The potential subjects were screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects were instructed to visit the facility as per the below visits.

* Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations
* Visit 02 (Day 28): Treatment Period, Evaluations
* Visit 03 (Day 56): Evaluations, End of Study Visit Subjects were pre-screened by the screening department of NovoBliss Research. Subjects were called on the telephone by the recruiting department prior to the enrolment visit. Subjects were told during screening (prior to enrolment) not to wear any facial make-up or use any hair product on the study visit day.

Assessment of efficacy parameters before test treatment usage was done on day 1, and after test treatment usage was done on day 28, and day 56 as listed below.

* General Appearance of Hair i.e., hair volume, hair reflection, hair plasticity, hair density, hair smoothness, hair oiliness, hair shininess.
* General Appearance of Scalp i.e., Scalp itchiness, redness, scaling.
* CASLite Nova: Hair Density, Thickness, scalp condition
* Visioscan (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness,
* Skin Colorimeter CL 400: Right cheek skin colour evenness L\*, a\* b\* and RGB, ITA Angle
* DermaLab®Combo - skin elasticity (Right cheek)
* MoitureMeterEPiD: Skin Hydration (Right cheek)
* Vapometer: Skin Barrier function - Transepidermal water loss (Right cheek)
* Physician Global Assessment for improvement in brittle nails - Day 01 and Day 56
* Serum Ferratin Biomarker test (Day 1 as baseline and Day 56)
* Digital Photographs: Facial photographs Before test treatment usage and after test treatment usage.
* Subjective Product Perception Assessment regarding the test product's effect on hair and skin firmness, appearance, nails etc

Eligibility criteria: Inclusion Criteria:

1. Age: 30 to 55 years (both inclusive) at the time of consent.
2. Sex: Healthy males and non-pregnant/non-lactating females.
3. Females of childbearing potential must have a self-reported negative pregnancy test.
4. Subjects are generally in good health.
5. Subject with self-proclaimed nonpathological thin, dry and brittle hair.
6. Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
7. Subject has a score of at least "mild skin aging" based on PGA at screening visit.
8. Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
9. Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
10. 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.
11. Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
12. Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
13. 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.
14. 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.
15. Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
16. Subjects are willing to give written informed consent and are willing to follow the study procedure.
17. Subjects who have used other marketed products for hair thinning in the past.
18. 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 product for the entire duration of the study.
19. Willing to use test product throughout the study period

Exclusion Criteria:

1. Subjects with a history of hair thinning/hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.
2. Subject has a history of allergy or sensitivity to the test treatment ingredients like sesbania agati and others etc.
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. Subject who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.
14. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
15. Pregnant or breastfeeding or planning to become pregnant during the study period.
16. History of chronic illness which may influence the cutaneous state.
17. Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp/skin care products within the last four weeks.

Primary outcomes:
measure: Change in Hair Density
timeFrame: Day 01,Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Hair Thickness
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Scalp Condition
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Facial Wrinkle
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Fine Lines
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Secondary outcomes:
measure: Change in Physician Global Assessment (PGA) scoring
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Glogau Skin Age
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Skin Colour
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Skin Elasticity
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Skin Hydration
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Skin barrier Function
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in Serum Ferritin
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Change in brittle nails
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Noticeable Improvement in Facial Photograph
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
measure: Subjective Perception Questionnaires
timeFrame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Other outcomes:
Locations:
city: Gandhi Nagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: Medical Director
name: Dr. Nayan K Patel, MBBS
role: PRINCIPAL_INVESTIGATOR
References: