Purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily use of novel dietary supplements over 24 weeks is able strengthen and promote growth of hairs, improve their density and thickness and reduce hair loss in adults with self-perceived thinning hair.
Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study to evaluate whether the daily use of novel dietary supplements over 24 weeks will strengthen and promote density and quality of hair in adults with self-perceived thinning hair. Study population will be divided in three groups - 32 in active groups and 20 in placebo group. Test group 1 (TG1) will receive investigational product 1 (CPMSM: containing fish collagen, methylsulphonylmethane (MSM), vitamins and zinc), test group 2 (TG2) will receive investigational product 2 (HC+: containing mixture of herbal extracts, B-vitamins and zinc) and the placebo group (PG) will receive placebo product without any of the active ingredients (PL, no active ingredients). Participants will test continuous administration of placebo or investigational products (in the form of syrups) for 24 weeks in order to demonstrate and assess multiple-dose effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
Test group 1 will receive investigational product 1 (CPMSM: daily dose 25 mL contains: Hydrolyzed fish collagen 5 g, methylsulphonylmethane (MSM) 1,5 g, Biotin 150 μg, Vitamin B6 1,6 mg, Zinc 2 mg, Vitamin C 120 mg).
Test group 2 (TG2) will receive investigational product 2 (HC+: daily dose 25 mL contains: Niacin 16 mg, Pantothenic acid 6 mg, Biotin 500 μg, Vitamin B6 1,4 mg, Folic acid 200 μg, Zinc 2 mg, Pea sprout extract 100 mg, Horsetail aerial parts extract 70 mg, Ashwagandha root extract 40 mg, Saw palmetto fruit extract 40 mg, Nettle leaves extract 30 mg, Grape seed extract 10 mg).
VIST - Faculty of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia
Change of hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of hair density from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair density will be assessed through trichoscopy using H2H matching procedure. Results will be analysed for whole sample and separately for men and women.
Time frame: 24-weeks
Change of scalp sebum from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of scalp sebum from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Scalp sebum will be measured using DermaLab SkinLab sebum module.
Time frame: 24 weeks
Change of hair thickness from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of hair thickness from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair thickness will be assessed through trichoscopy using H2H matching procedure and average hair thickness determined.
Time frame: 24-weeks
Change of hair loss from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of hair loss from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair loss will be assessed through Hair comb test.
Time frame: 24-weeks
Change of terminal hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
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Placebo group (PG) will receive placebo product without any of the active ingredients (PL, daily dose 25 mL: no active ingredients).
Significant change of hair density from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair density will be assessed through trichoscopy using H2H matching procedure. Results will be analysed for whole sample and separately for men and women.
Time frame: 24 weeks