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

NCT06565117 | Completed

• 1 other identifier: XYFY2022-KL323-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adult Atopic Dermatitis

Keywords

Adult Atopic Dermatitis; Efficacy of Dipotassium Glycyrrhizinate Emollients

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

A:Emollient for systemic application

EXPERIMENTAL

Emollient for systemic application

Drug: White yu green skin lotion

B:Emollient was applied locally

EXPERIMENTAL

Apply skin lotion in locally affected skin areas or in areas previously affected by AD

Drug: White yu green skin lotion

C:No moisturizer

NO INTERVENTION

No moisturize

Interventions

White yu green skin lotion DRUG

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

A:Emollient for systemic application; B:Emollient was applied locally

Eligibility Criteria

• Age: 17 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 21, 2024
• Study Start: October 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)