Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin

NCT03350893 | Completed

• 1 other identifier: 17-047-A2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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 plantarum cream on skin health.

Conditions

Skin Problems

Outcome Measures

Primary Outcomes (1)

• Skin Diagnosis

  The changes of skin condition by VISIA Complexion Analysis System

  Baseline, 4 weeks and 8 weeks

Secondary Outcomes (2)

• Skin Moisture

  Baseline, 4 weeks and 8 weeks

• Skin Color

  Baseline, 4 weeks and 8 weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Emulsion base without probiotics

Other: Emulsion base

Active Group

EXPERIMENTAL

Emulsion base with probiotics

Combination Product: Emulsion base with probiotics

Interventions

Emulsion base with probiotics COMBINATION_PRODUCT

Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide, Heat-killed L. plantarum powders (1x10\^9 cells/ g-cream)

Also known as: Active Group

Active Group

Emulsion base OTHER

Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers between the ages of 20-60.

You may not qualify if:

• Subjects with photosensitivity (Sun allergy).
• Subjects are undergoing medical therapy for skin diseases.
• Subjects with severe hyperpigmentation.
• Subjects with diabetes.
• Subjects with cosmetics allergy.
• Subjects who have recently participated laser therapies or other treatments are not suitable for sun.

Sponsors & Collaborators

• GenMont Biotech Incorporation: lead
• Chia Nan University of Pharmacy and Science: collaborator

Study Sites (1)

Chia Nan University of Pharmacy and Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Interventions

Probiotics; Control Groups

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ching-Gong Lin, PhD

  Chia Nan University of Pharmacy and Science, Taiwan, R.O.C.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel, Open Label Study

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 22, 2017
• Study Start: September 18, 2017
• Primary Completion: July 25, 2018
• Study Completion: August 31, 2018
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

TW (1)