Clinical Trial of an Ointment in Patients With Mild and Moderate Atopic Dermatitis

NCT07653386 | Completed DMC

• 1 other identifier: 24.10.VVI
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis (AD) is a chronic skin disorder, which negatively impacts up to 20% children and 3% adults in the world. The main AD treatments aim to regress clinical manifestations, improve and restore skin lesions. Daily moisturizing has also been shown to have the ability to protect the skin, increase skin elasticity and reduce the severity of AD. In the past few decades, Korea has been a well-known country with cosmetic companies and products derived from nature. Carboexpert is also one of them. Since its inception, the company has focused on researching and developing herbal extracts in skin care cosmetic products, typically the product Theraphytoabel Theraphyto Intensive-Cure Ointment. The product uses a high concentration of extract from Syzygium formosum (Wall) masam leaves originating from Vietnam. This is a medicinal herb that has been used in Vietnam for hundreds of years. Folk remedies in Vietnam use hot water leaf extract of this plant to treat urticaria and rashes. Previous studies have shown that leaf extract has also been shown to be very effective against gram-positive bacteria. The study in 2018 also demonstrated that the ethanol extract of S. formosum leaves was effective in reducing food allergy on mouse model. Based on the above evidences, this study will evaluate and compare the effectiveness and safety between Theraphytoabel Theraphyto Intensive-Cure Ointment product and commercial moisturizers which using in Vinmec on moderate and mild AD patients at Vinmec International Hospital Times City, Hanoi.

Conditions

Mild and Moderate Atopic Dermatitis Patients; Atopic Dermatitis (AD)

Keywords

Steroid-sparing; Th2 cytokines; S. formosum-containing ointment; atopic dermatitis; clinical trial; Transepidermal water loss (TEWL); stratum corneum hydration (SCH); Scoring atopic dermatitis (SCORAD)

Outcome Measures

Primary Outcomes (1)

• Clinical assessment of AD severity

  AD global severity will be assessed using the SCORAD index, a validated clinical tool. The intensity of redness, swelling, oozing/ crusting, scratch marks, lichenification and dryness will be measured over the whole body. Subjective symptoms of itch and sleeplessness were measured and skin lesion photographs were taken at every visit.

  week 0, 4, 8, 12

Secondary Outcomes (3)

• Assessment of changes in transepidermal water loss

  All patients will be measured at week 0 (baseline), 4, 8, 12.

• Accessment the changes of Stratum corneum hydration (SCH)

  week 0 (baseline), 4, 8, 12

• Evaluate changes in cytokine levels

  week 0, 12

Other Outcomes (2)

• Evaluate the safety of the products on AD patient

  Week 4, 8, 12

• Evaluate patient's satisfaction after using product

  week 12

Study Arms (2)

Commercial group

ACTIVE COMPARATOR

Commercial moisturizer group will be applied standard therapy by topical commercial moisturizers using in Vinmec combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with or without topical corticosteroids.

Other: commercial moisturizer

Theraphyto group

EXPERIMENTAL

S. formosum-containing ointment group will be applied standard therapy by topical Theraphytoabel Theraphyto Intensive-Cure Ointment combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with topical corticosteroids.

Other: S.formosum-containing ointment

Interventions

S.formosum-containing ointment OTHER

The test ointment used in this study is Theraphytoabel Theraphyto Intensive-Cure Ointment (Carboexpert Inc., Daejeon, Korea), which contains various components, including herbal extracts. The content of S. Formosum leaf Extract is 0.35%

Also known as: Theraphytoabel Theraphyto Intensive-Cure Ointment

Theraphyto group

commercial moisturizer OTHER

One of the moisturizers approved for use in patients with atopic dermatitis at Vinmec Times City

Commercial group

Eligibility Criteria

• Age: 1 Year - 30 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 1 and 30 years of age
• Definitive diagnosis of AD according to the Hanifin and Rajka criteria SCORAD scores: \< 25: mild AD, 26- 50: moderate AD
• Total IgE and eosinophil measurements could be performed to access disease severity

You may not qualify if:

• Non-adherence to therapy
• Presence of other active skin diseases
• Severe AD within 1 month prior to enrollment
• Any concomitant disease that in the investigators' judgment, could interdere with treatment
• Current systemic treatment or use of immunosuppressive or immunomodulatory agents

Sponsors & Collaborators

• VinUniversity: lead

Study Sites (1)

Vinmec - VinUni Institute of Immunology, VinUniversity

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Research Specialist, assistant professor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 17, 2026
• Study Start: February 23, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

VN (1)