Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin

August 14, 2019 updated by: GenMont Biotech Incorporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face skin conditions such as moisturizing, whitening, anti-wrinkle and so on.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 71710
        • Chia Nan University of Pharmacy and Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers between the ages of 20-60.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Emulsion base without probiotics
Other: Emulsion base
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
Other Names:
  • Control Group
Experimental: Active Group
Emulsion base with probiotics
Combination product: Emulsion base with probiotics
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)
Other Names:
  • Active Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Diagnosis
Time Frame: Baseline, 4 weeks and 8 weeks
The changes of skin condition by VISIA Complexion Analysis System
Baseline, 4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Moisture
Time Frame: Baseline, 4 weeks and 8 weeks
The changes of skin moisture by Skicon-200EX and Corneometer CM 825
Baseline, 4 weeks and 8 weeks
Skin Color
Time Frame: Baseline, 4 weeks and 8 weeks
The changes of skin color by DermaSpectrometer
Baseline, 4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenMont Biotech Incorporation

Collaborators

Chia Nan University of Pharmacy and Science

Investigators

  • Study Chair: Ching-Gong Lin, PhD, Chia Nan University of Pharmacy and Science, Taiwan, R.O.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

July 25, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 17-047-A2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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