Efficacy of Dipotassium Glycyrrhizinate Emollients in the Maintenance Treatment of Adult Atopic Dermatitis

Efficacy of Dipotassium Glycyrrhizinate Emollients in the Maintenance Treatment of Adult Atopic Dermatitis: A Single-Center Randomized Controlled Study

To investigate whether emollients containing dipotassium glycyrrhizinate have a sustained improvement in the clinical severity of mild to moderate atopic dermatitis in adult.

Study Overview

• Status: Completed
• Conditions: Adult Atopic Dermatitis
• Intervention / Treatment: Drug: White yu green skin lotion

Detailed Description

Atopic dermatitis (atopic eczema, AD) is a common skin inflammatory disease, dry skin and itchy skin is a significant symptom of most AD, often accompany patients for life, seriously affecting the physical and mental health and work life of patients. The number of AD patients is increasing worldwide, while the prevalence rate in China has increased more significantly in the past 10 years. It is characterized by persistent skin dryness and a reduced function of the skin as a barrier to the external environment. Encourage the free use of moisturizers (emollients) as a baseline treatment for AD and add anti-inflammatory therapy as needed. Currently, topical corticosteroids are still the first-line treatment options. However, studies have confirmed that patients with AD are cautious about the use of topical corticosteroids. Maintaining the humidity of the skin and restoring the barrier function of the skin is the basis of the treatment of atopic dermatitis. And studies have shown that regular use of emollients can improve skin hydration, restore the skin barrier, reduce the frequency of attacks, and reduce the use of topical corticosteroids. In patients with AD, daily use of moisturizing emollients enhances the response to topical corticosteroid therapy, reduce percutaneous water loss (TEWL), restore the skin barrier and promote hydration, and can prevent or reduce AD attacks by improving the associated skin barrier defects, prolonging the time between AD episodes. The purpose of this study is to see whether emollients have sustained improvement on the clinical severity of adult atopic dermatitis in maintenance phase.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221002
      • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meet the Williams diagnostic criteria
• SCORAD scores < 50 points, classified according to the severity levels of SCORAD scores, where scores of 0-25 are categorized as mild, and scores of 26-50 are categorized as moderate
• No gender limit, age between 18-65 years old.

Exclusion Criteria:

• Acute disease with erosion, exudation, secondary infection
• There are currently other active inflammatory skin diseases
• Antihistamine was used within 2 weeks prior to enrollment
• Patients treated with emollients and receiving topical drugs (such as glucocorticoids and calcineurin inhibitors) within 1 week before enrollment
• Patients have used phototherapy, systemic corticosteroids, immunosuppressants (such as cyclosporine, azathioprine, or immunoglobulin, etc.) within 4 weeks before enrollment
• The systematic withdrawal time of biological agents or JAK inhibitor (dupilumab, omalizumab, et al) was less than 12 weeks
• Malignant tumors, chronic systemic diseases (such as diabetes mellitus, hypothyroidism), or other acute and chronic infections
• Those known to be allergic to the ingredients of emollient or Hydrocortisone cream
• Patients who have attended or are attending other clinical investigators within three months
• Patients judged unsuitable by the investigator to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A:Emollient for systemic application; Emollient for systemic application	Drug: White yu green skin lotion; Group A: Systemic emollient was applied twice daily for 8 weeks Group B: Continue applying skin lotion twice daily in locally affected skin areas or in areas previously affected by AD for 8 weeks
Experimental: B:Emollient was applied locally; Apply skin lotion in locally affected skin areas or in areas previously affected by AD	Drug: White yu green skin lotion; Group A: Systemic emollient was applied twice daily for 8 weeks Group B: Continue applying skin lotion twice daily in locally affected skin areas or in areas previously affected by AD for 8 weeks
No Intervention: C:No moisturizer; No moisturize

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCORAD	Objective severity of the clinical signs of atopic dermatitis	Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
POEM	Patient-oriented eczema measurement scores	Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
NRS	Pain digital score	Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
ADCT	Long-term disease control	Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
DLQI	Quality of life index in dermatology	Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Adult Atopic Dermatitis; Efficacy of Dipotassium Glycyrrhizinate Emollients
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: XYFY2022-KL323-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No