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

Sponsor

BioGaia AB (Industry)

Overall Status

Completed

CT.gov ID

NCT03632174

Collaborator

(none)

Enrollment

Location

Arms

8.8

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Other: Topical Ointment with L. reuteri Other: Topical Ointment without L. reuteri	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Comparison of two cosmetic productsComparison of two cosmetic products

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 21, 2019

Actual Primary Completion Date :

Sep 2, 2019

Actual Study Completion Date :

Oct 16, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator [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)

Secondary Outcome Measures

Change in SCORAD index over 8 week period [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 [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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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