NCT07067541

Brief Summary

Twenty-five patients with atopic dermatitis applied lidocaine cream plus a moisturizer to the right limb and lidocaine cream alone to the left limb, twice daily for four weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 1, 2025

Last Update Submit

July 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in SCORAD (SCORing Atopic Dermatitis) from baseline

    For each patient, a score will be obtained at baseline, after 4 weeks. The minimum score is 0 (best outcome) and the maximum score is 103 (worst outcome).

    4 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR
Drug: Control lidocaine cream

Experimental group

EXPERIMENTAL
Drug: Experimental lidocaine cream + moisturizer cream

Interventions

lidocaine cream alone

Control Group

lidocaine cream + moisturizer cream

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged 18-65 years.
  • Clinical diagnosis of atopic dermatitis according to the 2020 Guidelines for the Diagnosis and Treatment of Atopic Dermatitis in China (symmetrical eczematous lesions for ≥6 months plus personal/family atopy history or elevated IgE/eosinophilia).
  • Voluntarily signed informed consent form.

You may not qualify if:

  • Active heart, liver, kidney, or other serious systemic illness.
  • History of viral or bacterial infection within 1 month prior to enrollment.
  • Immunocompromised patients or those receiving systemic immunosuppressive therapy.
  • Known allergy to lidocaine, moisturizer components, or any study-related topical agents.
  • Pregnant or breastfeeding women.
  • Use of topical corticosteroids or calcineurin inhibitors within 2 weeks prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 16, 2025

Study Start

October 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations