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Completed

NCT Number: NCT06565117

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

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

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Key information

Age range

17 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. SCORAD

    Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

    Objective severity of the clinical signs of atopic dermatitis

  2. POEM

    Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

    Patient-oriented eczema measurement scores

  3. NRS

    Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

    Pain digital score

  4. ADCT

    Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

    Long-term disease control

  5. DLQI

    Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

    Quality of life index in dermatology

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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