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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Ointment with L. reuteri | Experimental | Adult subjects presenting with mild-moderate Atopic Dermatitis |
|
| Topical Ointment without L. reuteri | Experimental | Adult subjects presenting with mild-moderate Atopic Dermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Ointment with L. reuteri | Other | Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burgert Jaques Van Wyk, MB, ChB | South African Medical Association | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit 12B, Waverly Business Park | Cape Town | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12589361 | Background | 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. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Comparison of two cosmetic products
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|
| 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 |
|
|
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 |
| 4 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |