HL-300 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis

Sponsor
Hangzhou Highlightll Pharmaceutical Co., Ltd
Study ID
NCT07629778
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HL-300 — DRUG
    Group A receives the investigational product at a concentration of 0.25%, BID,4 weeks.
  • Placebo — DRUG
    BID, day 7.
  • HL-300 — DRUG
    Group B receives the investigational product at a concentration of 0.5%, BID,4 weeks.
  • HL-300 — DRUG
    Group A receives the investigational product at a concentration of 1.0%, BID,4 weeks.

Study Details

This study is a randomized, double-blind, placebo-controlled, multicenter Phase Ib/II clinical study designed to evaluate the efficacy, safety, and PK characteristics of HL-300 ointment with different concentration regimens for mild-to-moderate AD.

Key Dates

First listed
Jun 5, 2026
Start date
May 26, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group D
  • Experimental: Group A
    Group A：0.25%
  • Experimental: Group B
    Group B：0.5%
  • Experimental: Group C
    Group C：1.0%

Primary Outcome Measure

Eczema Area and Severity Index (EASI) [ Time Frame: 4 weeks ]

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