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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632174
• Other study ID #: CSUB0167
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: October 16, 2019

Study information

• Verified date: October 2019
• Source: BioGaia AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 16, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Topical Ointment with L. reuteri
Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
• Topical Ointment without L. reuteri
Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body

Locations

Country	Name	City	State
South Africa	Unit 12B, Waverly Business Park	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
BioGaia AB

Country where clinical trial is conducted

South Africa, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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