A Study of JYP0066 Cream in Mild-to-Moderate Atopic Dermatitis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-75
SponsorGuangzhou JOYO Pharma Co., Ltd

About this trial

This is a Phase 2 research study testing an investigational topical cream called JYP0066 for the treatment of mild-to-moderate atopic dermatitis (eczema) in teenagers (12-17 years old) and adults. The study will check whether JYP0066 cream can reduce eczema signs and symptoms such as redness, itching, dryness, and skin thickening, and whether it is safe and well tolerated.

Participants will be randomly assigned to one of four groups: they will apply either 4%, 3%, or 2% JYP0066 cream, or a matching placebo cream, to eczema-affected skin twice a day for 8 weeks. All creams will look the same. This helps the study compare which concentration works best and how safe each one is.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is ≥12 and ≤75 years of age at the time of signing informed consent; male or female.

Disqualifiers

Presence of other skin diseases or skin infections that may interfere with AD assessment at screening/baseline, or large tattoos, birthmarks, or scars over AD lesions at screening/baseline.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JYP0066 4% topical cream

    Drug

    applied twice daily (BID) to affected skin areas for 8 weeks

  • 3% JYP0066 topical cream

    Drug

    applied twice daily (BID) for 8 weeks

  • 2% JYP0066 topical cream

    Drug

    applied twice daily (BID) for 8 weeks

  • Matching placebo cream (vehicle, no active ingredient)

    Drug

    applied twice daily (BID) for 8 weeks

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: 4% JYP0066 topical cream - applied twice daily (BID) to affected skin areas for 8 weeksExperimental treatment 1 intervention
Group B: 3% JYP0066 topical cream - applied twice daily (BID) for 8 weeksExperimental treatment 1 intervention
Group C: 2% JYP0066 topical cream - applied twice daily (BID) for 8 weeksExperimental treatment 1 intervention
Group D: Matching placebo cream (vehicle, no active ingredient) - applied twice daily (BID) for 8 weeksPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from baseline in EASI score at Week 8

Time frame
Baseline to Week 8

Secondary outcomes

1

Proportion of participants achieving EASI 50/75/90 at Weeks 1, 2, 4, and 8

Time frame
Weeks 1, 2, 4, 8
2

Percent change from baseline in EASI score at Weeks 1, 2, and 4

Time frame
Weeks 1, 2, 4
3

Proportion of participants with vIGA-AD response at Weeks 1, 2, 4, 8

Time frame
Weeks 1, 2, 4, 8
4

Proportion of participants with vIGA-AD score 0/1 at Weeks 1, 2, 4, 8

Time frame
Weeks 1, 2, 4, 8

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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