NCT03632174

Brief Summary

The study consists in the application of 2 investigational products (one group per investigational product) under normal conditions of use, in adult participants with Atopic Dermatitis. It is carried out on cosmetic products, with the aim to further confirm safety of these products

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

August 1, 2018

Last Update Submit

October 18, 2019

Conditions

Atopic Dermatitis

Keywords

ProbioticAtopic DermatitisLactobacillus reuteri

Outcome Measures

Primary Outcomes (1)

  • Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator

    Cutaneous acceptability is assessed on the basis of clinical examination of the skin for physical signs (erythema, oedema, dryness) linked to the use of the investigational product and also evaluation the functional signs (prickling, tightness, heating)

    4 weeks

Secondary Outcomes (2)

  • Change in SCORAD index over 8 week period

    baseline, at 4 and 8 weeks

  • Change in Local SCORAD index

    baseline, at 4, and 8 weeks

Other Outcomes (1)

  • Appraisal of cosmetic acceptability of the investigational products by participant questionnaire

    4 weeks

Study Arms (2)

Topical Ointment with L. reuteri

EXPERIMENTAL

Adult subjects presenting with mild-moderate Atopic Dermatitis

Other: Topical Ointment with L. reuteri

Topical Ointment without L. reuteri

EXPERIMENTAL

Adult subjects presenting with mild-moderate Atopic Dermatitis

Other: Topical Ointment without L. reuteri

Interventions

Topical Ointment with L. reuteriOTHER

Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body

Also known as: Probiotic ointment A
Topical Ointment with L. reuteri
Topical Ointment without L. reuteriOTHER

Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body

Also known as: Non Probiotic ointment B
Topical Ointment without L. reuteri

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant has not been on a course of long term treatment in particular with aspirin, products containing aspirin, anti-inflammatories, antibiotics, antihistamines, corticoids
  • Participant presenting with mild to moderate atopic dermatitis according to the definition of the UK Working Party's Diagnostic Criteria for Atopic Dermatitis (SCORAD index \>25)
  • Participant presenting with a current lesion of Atopic Dermatitis on defined area

You may not qualify if:

  • Participant is pregnant, breast feeding or not willing to take the necessary precautions to avoid pregnancy during the study
  • Participant having background of intolerance or allergy
  • Participant not respecting the washout period during which a person may not be involved in any other biomedical research projects
  • Participant having modified his/her cosmetic habits during the last two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit 12B, Waverly Business Park

Cape Town, South Africa

Location

Related Publications (1)

  • Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95. doi: 10.1067/mai.2003.389.

    PMID: 12589361BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Burgert Jaques Van Wyk, MB, ChB

    South African Medical Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Comparison of two cosmetic products
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 15, 2018

Study Start

January 21, 2019

Primary Completion

September 2, 2019

Study Completion

October 16, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)