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CompletedNCT03350893Updated Aug 16, 2019

Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin

An interventional study of Emulsion base with probiotics and Emulsion base in Skin Problems, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-16.

Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Skin Problems
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers between the ages of 20-60.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Placebo comparator
    Control Group

    Emulsion base without probiotics

    Other: Emulsion base

  • Experimental
    Active Group

    Emulsion base with probiotics

    Combination Product: Emulsion base with probiotics

Interventions

  • Combination productEmulsion 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)

    Also known as: Active Group

  • OtherEmulsion 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

    Also known as: Control Group

05

What researchers measure

Primary outcomes

  1. Skin Diagnosis

    The changes of skin condition by VISIA Complexion Analysis System

    Time frame: Baseline, 4 weeks and 8 weeks

Secondary outcomes

  1. Skin Moisture

    The changes of skin moisture by Skicon-200EX and Corneometer CM 825

    Time frame: Baseline, 4 weeks and 8 weeks

  2. Skin Color

    The changes of skin color by DermaSpectrometer

    Time frame: Baseline, 4 weeks and 8 weeks

06

Study locations

1 site
  • Chia Nan University of Pharmacy and Science
    Tainan, 71710, Taiwan
07

Registry details

Key details

Study ID
NCT03350893
Lead sponsor
GenMont Biotech Incorporation
Collaborators
Chia Nan University of Pharmacy and Science
Responsible party
Sponsor
First posted
Nov 22, 2017
Start date
Sep 18, 2017
Primary completion
Jul 25, 2018
Completion
Aug 31, 2018
Last update
Aug 16, 2019

Study contacts

Ching-Gong Lin, PhD
study chair · Chia Nan University of Pharmacy and Science, Taiwan, R.O.C.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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