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Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632174
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
BioGaia AB

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date October 22, 2019
Actual Study Start Date  ICMJE January 21, 2019
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator [ Time Frame: 4 weeks ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Change in SCORAD index over 8 week period [ Time Frame: baseline, at 4 and 8 weeks ]
    Clinical evaluation by the dermatologist investigator to assess change in skin conditions to each parameter of "SCORing Atopic Dermatitis" (SCORAD) (erythema, edema, xerosis) and participant symptoms: pruritus and sleep quality
  • Change in Local SCORAD index [ Time Frame: baseline, at 4, and 8 weeks ]
    Change evaluated by the dermatologist investigator at each visit, on the recurrent lesion (defined area) and control area selected at baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 14, 2018)
Appraisal of cosmetic acceptability of the investigational products by participant questionnaire [ Time Frame: 4 weeks ]
Cosmetic acceptability of the products through participant filling in questionnaire adapted to the products, elaborated in collaboration with the study monitor. The questionnaire will address functional and physical signs of a reaction (application frequency, nature, location, intensity, duration) Conclusion on cutaneous acceptability: Very good/ Good / Moderately Good / Bad
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
Official Title  ICMJE Clinical Study for the Evaluation and Comparison of Cutaneous Acceptability and the Efficacy of 2 Cosmetic Products, Under Normal Conditions of Use, in Adult Participants With Atopic Dermatitis
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

Detailed Description

Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects of Lactobacillus reuteri have been extensively studied in the gastrointestinal tract but it is clear that other areas are also interesting for the use of probiotics.

Atopic Dermatitis is a relapsing inflammatory skin disease appearing on persons with a genetic predisposition of allergic pathology. AD generally starts in childhood, however in some cases can continue into adult hood, in at least 10% of cases. AD can effect a persons quality of life and in the chronic stage it can present with dry skin and lichenification.

Research has shown that probiotics have an antimicrobial, anti-inflammatory and barrier function effect, and could therefore be used on subjects with Atopic Dermatitis to relieve and protect.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Comparison of two cosmetic products
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Other: Topical Ointment with L. reuteri
    Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
    Other Name: Probiotic ointment A
  • Other: Topical Ointment without L. reuteri
    Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
    Other Name: Non Probiotic ointment B
Study Arms  ICMJE
  • Experimental: Topical Ointment with L. reuteri
    Adult subjects presenting with mild-moderate Atopic Dermatitis
    Intervention: Other: Topical Ointment with L. reuteri
  • Experimental: Topical Ointment without L. reuteri
    Adult subjects presenting with mild-moderate Atopic Dermatitis
    Intervention: Other: Topical Ointment without L. reuteri
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
40
Actual Study Completion Date  ICMJE October 16, 2019
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 skin exposed to sunlight within 2 weeks preceding the inclusion
  • Participant having modified his/her cosmetic habits during the last two weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632174
Other Study ID Numbers  ICMJE CSUB0167
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BioGaia AB
Study Sponsor  ICMJE BioGaia AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Burgert Jaques Van Wyk, MB, ChB South African Medical Association
PRS Account BioGaia AB
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP