Adult Atopic DermatitisNCT06565117
Efficacy of Dipotassium Glycyrrhizinate Emollients in the Maintenance Treatment of Adult Atopic Dermatitis
A study testing White yu green skin lotion in people with Adult Atopic Dermatitis, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
To investigate whether emollients containing dipotassium glycyrrhizinate have a sustained improvement in the clinical severity of mild to moderate atopic dermatitis in adult. Read more about this study
- Who is it for?
- Ages 17 to 64 years
- Conditions the study is for
- Adult Atopic Dermatitis
- What is being tested?
- White yu green skin lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
About this study
Official title: 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.
Read the 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.
- Conditions
- Adult Atopic Dermatitis
- Being tested
- White yu green skin lotion
- Keywords
- Adult Atopic Dermatitis, Efficacy of Dipotassium Glycyrrhizinate Emollients
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White yu green skin lotionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| A:Emollient for systemic application | Experimental | Emollient for systemic application Receives: 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 Receives: Drug: White yu green skin lotion |
| C:No moisturizer | No intervention | No moisturize |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD
Objective severity of the clinical signs of atopic dermatitis
Measured: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
POEM
Patient-oriented eczema measurement scores
Measured: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
NRS
Pain digital score
Measured: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
ADCT
Long-term disease control
Measured: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
DLQI
Quality of life index in dermatology
Measured: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Oct 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565117
- Sponsor's protocol ID
- XYFY2022-KL323-02
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dipotassium Glycyrrhizinate Emollients in the Maintenance Treatment of Adult Atopic Dermatitis: A Single-Center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06565117
- Acronym / sponsor ID
- XYFY2022-KL323-02
- Conditions
- Adult Atopic Dermatitis
- Keywords
- Adult Atopic Dermatitis, Efficacy of Dipotassium Glycyrrhizinate Emollients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether emollients containing dipotassium glycyrrhizinate have a sustained improvement in the clinical severity of mild to moderate atopic dermatitis in adult.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A:Emollient for systemic application | Experimental | Drug: White yu green skin lotionEmollient for systemic application |
| B:Emollient was applied locally | Experimental | Drug: White yu green skin lotionApply skin lotion in locally affected skin areas or in areas previously affected by AD |
| C:No moisturizer | No intervention | –No moisturize |
Who may qualify
- Ages
- 17 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White yu green skin lotionGroup 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 | Drug | A:Emollient for systemic application, B:Emollient was applied locally |
Primary outcome
SCORAD
Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
Objective severity of the clinical signs of atopic dermatitis
POEM
Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
Patient-oriented eczema measurement scores
NRS
Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
Pain digital score
ADCT
Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
Long-term disease control
DLQI
Time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks
Quality of life index in dermatology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White yu green skin lotion in people with Adult Atopic Dermatitis, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD (time frame: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.