The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

GenMont Biotech

Status and phase: Completed; Phase 2

Conditions: Skin Problems

Treatments: Combination Product: Test group Probiotic Shampoo; Combination Product: Placebo group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04566549

TSMH IRB 20-040-A

Details and patient eligibility

About

Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair healthcare.

Full description

To evaluate the safety and efficacy of hair products containing probiotics

Enrollment: 21 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers between the ages of 20-70.

Exclusion criteria

• Subjects are undergoing medical therapy for scalp, hair diseases or diabetes mellitus.
• Subjects with cosmetics allergy.
• Subjects had accepted the scalp surgery such as Follicular Unit Transpalnt, Follicular Unit Extraction in the past half year.
• Subjects with pregnancy or breast-feeding.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Shampoo base without probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance.

Treatment:

Combination Product: Placebo group

Test group

Active Comparator group

Description:

Shampoo base with probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance、Heat-killed Lactobacillus paracasei powders (5x10\^8 cells/ g-shampoo).

Treatment:

Combination Product: Test group Probiotic Shampoo