Clinical trial NCT06553417: Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis
Official title: Effectiveness and Tolerability of an Emollient 'Plus' Compared to Urea 10% in Patients With Mild-moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
skin barrier
moisturizer
bacterial lysate
clinical efficacy
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: L'Oreal
First posted: 2024-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis The main question it aims to answer is:

" To evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis age 18 years and above". Moisturizer application will be performed twice daily, 3 minutes after bathing, with a standardized dose using the Finger Tip Unit (FTU) method.


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥18 years
* AD patients who meet the criteria for AD diagnosis according to the Hanifin-Rajka criteria.
* Patients with mild-moderate AD according to the SCORAD index.
* Patients who have AD lesions on the hands and/or feet.
* Patients with good general condition.
* Patients are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Pregnant and lactating patients.
* Patients with a history of allergies to ingredients contained in moisturizers
* Patients who clinically have other skin diseases such as psoriasis, seborrheic dermatitis, contact dermatitis or AD with secondary infections that can affect the SCORAD index parameters, skin hydration, skin pH and side effects on the skin area being assessed.
* Patients receiving topical or systemic immunomodulatory and/or immunosuppressant therapy.
* Patients receiving topical and/or systemic antibiotic therapy
* Patients receiving systemic antihistamine therapy (patients who require antihistamines during the study will be recorded on the observation sheet)

Primary outcomes:
measure: SCORAD (Scoring Atopic Dermatitis)
timeFrame: Through study completion, 12 week
measure: PVAS (Pruritus Visual Analog Scale)
timeFrame: Through study completion, 12 week
measure: EASI (Eczema Area and Severity Index)
timeFrame: Through study completion, 12 week
measure: DLQI (Dermatology Life Quality Index)
timeFrame: Through study completion, 12 week
Secondary outcomes:
measure: Transepidermal Water Loss (TEWL)
timeFrame: Through study completion, 12 week
measure: Skin Hydration
timeFrame: Through study completion, 12 week
measure: Skin pH
timeFrame: Through study completion, 12 week
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital
state: East Java
Study officials:
References:
citation: Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.
citation: Zelenkova H, Kerob D, Salah S, Demessant-Flavigny AL. Impact of daily use of emollient 'plus' on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:27-34. doi: 10.1111/jdv.18947. Epub 2023 Apr 24.
citation: Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, Gieler U, Girolomoni G, Lau S, Muraro A, Czarnecka-Operacz M, Schafer T, Schmid-Grendelmeier P, Simon D, Szalai Z, Szepietowski JC, Taieb A, Torrelo A, Werfel T, Ring J; European Dermatology Forum (EDF), the European Academy of Dermatology and Venereology (EADV), the European Academy of Allergy and Clinical Immunology (EAACI), the European Task Force on Atopic Dermatitis (ETFAD), European Federation of Allergy and Airways Diseases Patients' Associations (EFA), the European Society for Dermatology and Psychiatry (ESDaP), the European Society of Pediatric Dermatology (ESPD), Global Allergy and Asthma European Network (GA2LEN) and the European Union of Medical Specialists (UEMS). Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018 May;32(5):657-682. doi: 10.1111/jdv.14891.
citation: Ch'ng CC. Rebalancing of the skin microbiome with an emollient 'plus' for effective management of atopic dermatitis: A mini review. Med J Malaysia. 2024 Mar;79(2):203-205.
citation: Gueniche A, Knaudt B, Schuck E, Volz T, Bastien P, Martin R, Rocken M, Breton L, Biedermann T. Effects of nonpathogenic gram-negative bacterium Vitreoscilla filiformis lysate on atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled clinical study. Br J Dermatol. 2008 Dec;159(6):1357-63. doi: 10.1111/j.1365-2133.2008.08836.x. Epub 2008 Sep 15.
citation: Wollenberg A, Kinberger M, Arents B, Aszodi N, Barbarot S, Bieber T, Brough HA, Pinton PC, Christen-Zaech S, Deleuran M, Dittmann M, Fosse N, Gaspar K, Gerbens LAA, Gieler U, Girolomoni G, Gregoriou S, Mortz CG, Nast A, Nygaard U, Rehbinder EM, Ring J, Rossi M, Roxburgh C, Serra-Baldrich E, Simon D, Szalai ZZ, Szepietowski JC, Torrelo A, Werfel T, Flohr C. First update of the living European guideline (EuroGuiDerm) on atopic eczema. J Eur Acad Dermatol Venereol. 2023 Nov;37(11):e1283-e1287. doi: 10.1111/jdv.19269. Epub 2023 Jul 17. No abstract available.
citation: Seite S, Zelenkova H, Martin R. Clinical efficacy of emollients in atopic dermatitis patients - relationship with the skin microbiota modification. Clin Cosmet Investig Dermatol. 2017 Jan 12;10:25-33. doi: 10.2147/CCID.S121910. eCollection 2017.
citation: Magnolo N, Jaenicke T, Tsianakas A, Czech W, Thaci D, Pinter A, Kerob D, Salah S, Luger TA. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:18-26. doi: 10.1111/jdv.18949. Epub 2023 Apr 24.