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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Cape Town, Sør-Afrika
- Unit 12B, Waverly Business Park
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Topical Ointment with L. reuteri
Adult subjects presenting with mild-moderate Atopic Dermatitis
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Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Andre navn:
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Eksperimentell: Topical Ointment without L. reuteri
Adult subjects presenting with mild-moderate Atopic Dermatitis
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Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator
Tidsramme: 4 weeks
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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)
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4 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in SCORAD index over 8 week period
Tidsramme: baseline, at 4 and 8 weeks
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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
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baseline, at 4 and 8 weeks
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Change in Local SCORAD index
Tidsramme: baseline, at 4, and 8 weeks
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Change evaluated by the dermatologist investigator at each visit, on the recurrent lesion (defined area) and control area selected at baseline
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baseline, at 4, and 8 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Appraisal of cosmetic acceptability of the investigational products by participant questionnaire
Tidsramme: 4 weeks
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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
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Burgert Jaques Van Wyk, MB, ChB, South African Medical Association
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSUB0167
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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