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ACTIVE NOT RECRUITING

NCT07520019

Study Evaluating the Effect of Nutra Harmony "Biotin, Collagen & Keratin Beauty Complex" Dietary Supplement on Hair Thickness and Hair Strength in Adults With Self-Perceived Thinning Hair

Sponsor: Nutra Harmony LLC

View on ClinicalTrials.gov

Summary

The Nutra Harmony "Biotin, Collagen \& Keratin Beauty Complex" is an oral food/dietary supplement specifically designed to Promote hair growth for people suffering from temporary thinning hair. The main goal of this clinical trial is to evaluate the efficacy of two different doses of the study supplement (with 5,000 mcg vs 10,000 mcg biotin). Product formula with 10,000 mcg biotin per serving was clinically tested and shows results in strengthening the hair and increasing hair thickness by promoting the growth of terminal hairs in subjects, ages 21-50 years of age, with self-perceived thinning hair associated with poor diet, stress, and hormonal influences when compared to using the placebo tablet.

Official title: A 3-Month, Randomized, Single-Blind, Two-Arm, Dose-Comparison Study Evaluating the Effect of Nutra Harmony "Biotin, Collagen &Amp; Keratin Beauty Complex" Dietary Supplement on Hair Thickness and Hair Strength in Adults With Self-Perceived Thinning Hair

Key Details

Gender

All

Age Range

21 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-15

Completion Date

2026-06-15

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Hair Thinning

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement: Complex with Biotin 5,000 mcg, Collagen, Keratin, Hyaluronic Acid.

Biotin, Collagen \& Keratin Beauty Complex" 25,000 mcg, 60 capsules, oral route of administration. (Low Dosage Biotin, 5,000 mcg per Serving)

DIETARY_SUPPLEMENT

Dietary Supplement: Complex with Biotin 10,000 mcg, Collagen, Keratin, Hyaluronic Acid.

Biotin, Collagen \& Keratin Beauty Complex" 30,000 mcg, 60 capsules, oral route of administration. (High Dosage Biotin, 10,000 mcg per Serving)

Inclusion Criteria: Participants must meet all of the following criteria: 1. Adults aged 21-50 years. 2. Generally healthy, as determined by medical history, physical exam, and available laboratory results from Visit 1 (Day -1/0). 3. Self-perceived thinning hair associated with diet, stress, or hormonal influences. 4. Willingness to maintain usual hair care routine, including shampoo frequency, and consistent haircut/color during the study. 5. Willingness to take the study supplement daily as instructed. 6. Willingness to avoid major changes in diet, medications, or exercise during the study and to notify the clinic of any changes. 7. Willingness to undergo all required assessments, including physical exam, vital signs, hematology, urine pregnancy test (if applicable), scalp exam, hair photography, and completion of the Hair Shedding Diary. 8. Fitzpatrick skin types I-IV. 9. Ability and willingness to provide signed informed consent. Exclusion Criteria: Participants will be excluded if they meet any of the following: 1. Known allergy or intolerance to any component of the study supplement (e.g., biotin, keratin, collagen, fish/seafood, acerola). 2. Known allergy or sensitivity to study-specified hair care products. 3. Pregnant, breastfeeding, or planning pregnancy during the study period. 4. Significant stress event (e.g., death in family, miscarriage) within the past 6 months. 5. Participation in another clinical study concurrently. 6. Initiation of hormonal therapy within the past 6 months (stable use ≥6 months allowed). 7. Current use of light therapy for hair loss. 8. Use of minoxidil or other hair growth medications within the last 3 months. 9. Current use of biotin, keratin, collagen, or similar supplements. 10. Use of prescription medications known to affect hair growth within the last 6 months. 11. Hair disorders other than self-perceived thinning hair (e.g., alopecia areata, scarring alopecia, androgenetic alopecia, telogen effluvium). 12. Uncontrolled chronic diseases (e.g., diabetes, hypertension, thyroid disorders). Stable, well-controlled conditions may be allowed at investigator discretion. 13. Active hepatitis, immune deficiency, HIV, or autoimmune disease. 14. Active dermatologic conditions that may interfere with assessments or increase risk (e.g., severe seborrheic dermatitis, psoriasis, advanced skin cancer). -

Locations (1)

Limited Liability Company Treatment and Diagnostic Center ADONIS Plus

Kyiv, Kyiv Oblast, Ukraine