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

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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Topical Ointment with L. reuteri; Other: Topical Ointment without L. reuteri

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: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Unit 12B, Waverly Business Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Ointment with L. reuteri; Adult subjects presenting with mild-moderate Atopic Dermatitis	Other: Topical Ointment with L. reuteri; Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body; Other Names: Probiotic ointment A
Experimental: Topical Ointment without L. reuteri; Adult subjects presenting with mild-moderate Atopic Dermatitis	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 Names: Non Probiotic ointment B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SCORAD index over 8 week period	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	baseline, at 4 and 8 weeks
Change in Local SCORAD index	Change evaluated by the dermatologist investigator at each visit, on the recurrent lesion (defined area) and control area selected at baseline	baseline, at 4, and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appraisal of cosmetic acceptability of the investigational products by participant questionnaire	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	4 weeks

Collaborators and Investigators

• Sponsor: BioGaia AB
• Investigators: Principal Investigator: Burgert Jaques Van Wyk, MB, ChB, South African Medical Association

Publications and helpful links

General 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. doi: 10.1067/mai.2003.389.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): October 16, 2019

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Probiotic; Atopic Dermatitis; Lactobacillus reuteri
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CSUB0167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No