Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis

NCT06553417 | Completed

• 1 other identifier: 2141/112/2/V/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis; skin barrier; moisturizer; bacterial lysate; clinical efficacy

Outcome Measures

Primary Outcomes (4)

• SCORAD (Scoring Atopic Dermatitis)

  * The SCORAD is a composite score that evaluates the extent and severity of atopic dermatitis. * The SCORAD scale ranges from 0 to 103, with higher scores indicating more severe disease. The ranges of the SCORAD (0-25 for 'mild' disease, and 25-50 for 'moderate' disease, \>50 for severe disease)

  Through study completion, 12 week

• PVAS (Pruritus Visual Analog Scale)

  * The PVAS is a 100 mm visual analog scale that assesses the severity of pruritus (itching) experienced by the patient. * The PVAS ranges from 0 (no itch) to 100 (worst imaginable itch).

  Through study completion, 12 week

• EASI (Eczema Area and Severity Index)

  * The EASI is a tool that measures the extent and severity of atopic dermatitis lesions. * The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe

  Through study completion, 12 week

• DLQI (Dermatology Life Quality Index)

  * The DLQI is a questionnaire that assesses the impact of skin diseases on a patient's quality of life. * The DLQI score ranges from 0 to 30, with higher scores indicating a greater impairment of quality of life.

  Through study completion, 12 week

Secondary Outcomes (3)

• Transepidermal Water Loss (TEWL)

  Through study completion, 12 week

• Skin Hydration

  Through study completion, 12 week

• Skin pH

  Through study completion, 12 week

Study Arms (2)

Aqua posae + microresyl

EXPERIMENTAL

• Participants in this arm will receive the moisturizer formulation containing aqua posae and microresyl.

Other: Aqua posae and microresyl

10% Urea

ACTIVE COMPARATOR

• Participants in this arm will receive the moisturizer formulation containing 10% urea.

Other: Urea 10%

Interventions

Aqua posae and microresyl OTHER

* This intervention involves the use of two topical products: * Aqua posae - a moisturizing agent * Microresyl - an active ingredient with potential therapeutic effects * Subjects in Group A will be instructed to apply these two products (aqua posae and microresyl) twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin. The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects.

Aqua posae + microresyl

Urea 10% OTHER

Intervention 2: Urea 10% * This intervention involves the use of a 10% urea-based topical moisturizing product. * Subjects in Group B will be instructed to apply the 10% urea moisturizer twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin. The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects.

10% Urea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• L'Oreal: collaborator

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, East Java, 60286, Indonesia

Location

Related Publications (8)

• 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.

  PMID: 22310478 BACKGROUND

• 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.

  PMID: 37092256 BACKGROUND

• 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.

  PMID: 29676534 BACKGROUND

• 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.

  PMID: 38553927 BACKGROUND

• 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.

  PMID: 18795916 BACKGROUND

• 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.

  PMID: 37328919 BACKGROUND

• 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.

  PMID: 28138262 BACKGROUND

• 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.

  PMID: 37092275 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

N,N'-11-bis((1Z,4Z)-7alphaH-germacra-1(10),4-dienyl)urea

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The moisturizer codes will be blinded (double-blind) until all study phases are completed. This ensures that the participants, investigators, and outcomes assessors are unaware of which intervention each participant is receiving during the study. This helps to minimize potential bias in the evaluation of the treatment outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: June 1, 2023
• Primary Completion: September 29, 2023
• Study Completion: December 29, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)