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A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients

ConditionMild to Moderate Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorHK inno.N Corporation

About this trial

This study aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult volunteers aged 19 or older when the informed consent is obtained.

Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980).

AD lesions that can be applied by investigational product

AD diagnosed by EASI score of mild (EASI < 16) or moderate (16 ≤ EASI <

Disqualifiers

Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders other than AD ( e.g., psoriasis, contact dermatitis, erythroderma)

Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders (e.g., hepatic, renal, Cardiovascular, respiratory, endocrine, neurological, hematological, immunological or immunodeficiency disease)

Subjects who have a history of malignant tumors within 5 years at screening (but, those who have passed five years without recurrence after active tumor treatment (surgery, chemotherapy, radiation therapy, etc.) can participate.)

Subjects who have clinically significant systemic or local skin infections or clinical signs of such infections within one week prior to the expeced initial application date (e.g., herpes simplex, shingles, chickenpox)

Trial design

Design model

Parallel

Treatments tested in this trial

  • IN-115314 Ointment 1%

    Drug

    Twice daily(BID), for 56 day

  • IN-115314 Ointment 3%

    Drug

    Twice daily(BID), for 56 day

  • IN-115314 Ointment placebo

    Drug

    Twice daily(BID), IN-115314 Ointment Placebo for 28 days+ IN-115314 Ointment 3% for 28 days

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: J1Experimental treatment 1 intervention
Group B: J3Experimental treatment 1 intervention
Group C: PJPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment

Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.

Time frame
4 weeks

Secondary outcomes

1

Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment

Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.

Time frame
1 week, 2 weeks
2

Changes in EASI (Eczema Area and Severity Index) score from the baseline after treatment

Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.

Time frame
1 week, 2 weeks, 4 weeks

Other outcomes

Sponsors and contacts

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

HK inno.N Corporation

Lead sponsor

Source ClinicalTrials.gov
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