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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02748993 |
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Date of registration:
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20/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
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Scientific title:
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A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02748993 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Kyuhan Kim, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female patients aged 24 months - 12 years
- Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria,
whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
- Who has applied stable amount of emollients daily before baseline visit
- Who voluntarily agreed to participate in the study and signed an informed consent
form.
Exclusion Criteria:
- Who has skin diseases other than atopic dermatitis or scar in the affected area which
can affect the study, determined by the study investigators.
- Who has clinically significant medical history or diseases involving liver, kidney,
neurological system, psychial disorder that can affect study results.
- Who has used systemic steroids, antibiotics, immunosuppressants, or received
photochemical therapy within 28 days before study drug administration.
- Who has used topical steroids, immunosuppressants or antibiotics to treat atopic
dermatitis within 14 days before study drug administration.
- Who has used or is expected to inevitably use prohibited concomitant medications
during the study.
- Women who is pregnant /breast-feeding, or who has childbearing potential and does not
use available contraceptives.
- Who has dosed other study medications within 30 days before screening.
- Who is determined ineligible for study participation by investigators for any other
reasons.
Age minimum:
24 Months
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: PAC-14028 Cream 0.1%
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Drug: PAC-14028 Cream Vehicle
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Drug: PAC-14028 Cream 1.0%
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Drug: PAC-14028 Cream 0.3%
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Primary Outcome(s)
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Blood concentrations of PAC-14028
[Time Frame: Day 1, Day 28]
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Success rate of Investigator's Global Assessment (IGA)
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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% Change of EASI (Eczema Area and Severity Index)
[Time Frame: 1, 2, 4 week(s)]
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Change of IGA (Investigator's Global Assessment)
[Time Frame: 1, 2, 4 week(s)]
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Patient satisfaction measurement
[Time Frame: 4 weeks]
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Change of SCORAD (Severity Scoring of Atopic Dermatitis)
[Time Frame: 1, 2, 4 week(s)]
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Secondary ID(s)
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AP-TRPV1_PII-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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