Health TrialsbyHealthPanel

A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.

ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Huaota Biopharmaceutical Co., Ltd.

About this trial

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

1. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.

Trial design

Design model

Crossover

Treatments tested in this trial

  • HB0043

    Drug

    300mg

  • Placebo

    Drug

    300mg

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: HB0043Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in inflammatory lesion counts

Absolute change from Baseline in the number of inflammatory acne lesions

Time frame
Week 16
2

Investigator's global assessment (IGA) - change from Baseline

Absolute change in IGA score from Baseline \[scores: 0-4; 0=clear, 4=severe\]

Time frame
Week 16

Secondary outcomes

1

Investigator's global assessment (IGA) - percentage of subjects with improvement

Percentage of subjects with at least two-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) \[scores: 0-4; 0=clear, 4=severe\]

Time frame
Week 2, 4, 8, 12, 16
2

Change in inflammatory lesion counts

Percentage change from Baseline in the number of inflammatory acne lesions

Time frame
Week 16
3

Investigator's global assessment (IGA) - percentage of subjects with improvement

Percentage of subjects with an IGA score of "clear" or "almost clear"

Time frame
Week 2, 4, 8, 12, 16
4

Investigator's global assessment (IGA) - percentage of subjects with improvement

Percentage of subjects with an IGA score of "clear" or "almost clear" and a reduction of at least two-grade compared to the baseline IGA score.

Time frame
Week 2, 4, 8, 12, 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Huaota Biopharmaceutical Co., Ltd.

Lead sponsor

Dermatology Hospital affiliated to Shandong First Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: