Skip to main content
OpenTrials
Completed

NCT Number: NCT03632174

Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit 12B, Waverly Business Park

Cape Town, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Ointment with L. reuteri

Other

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

Other names: Probiotic ointment A

Topical Ointment without L. reuteri

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

BioGaia AB

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.