Phase 2
Completed N=104
An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT02655679 ↗
Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Treatment-related Adverse Events (AEs) — 1; 3; 2; 6 Participants
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events (AEs) |
1; 3; 2; 6; 2 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Clinical Laboratory Values |
0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values |
0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for VTP-38543-001 |
0.546; 0.221; 2.34; 2.81; 2.28; 13.4 | — |
| SECONDARY Time to Maximum Plasma Concentrations (Tmax) for VTP-38543 |
5.5; 9; 4; 1; 6.5; 4 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543 |
2.27; 1.35; 20.0; 129; 104; 720 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543 |
2.27; 1.35; 20.0; 23.6; 22.2; 144 | — |
| SECONDARY Elimination Half-life (t½) for VTP-38543 |
NA; NA; NA; 58.6; 47.2; 246 | — |
| SECONDARY Percentage Change From Baseline in Total Body Surface Area (BSA) |
-39.09; -9.46; -17.39; -9.44; -28.51 | — |
| SECONDARY Percentage Change From Baseline in Investigator Global Assessments (IGA) Score |
-12.7; -16.7; -19.4; -6.1; -13.2 | — |
| SECONDARY Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score |
-23.473; -17.300; -24.453; -14.483; -18.630 | — |
| SECONDARY Percentage Change From Baseline Eczema Area and Severity Index (EASI) |
-36.26; -9.16; -26.99; -12.52; -27.10 | — |
| SECONDARY Percentage Change From Baseline in Pruritus VAS Score |
4.20; -20.07; -26.75; -25.80; -34.68 | — |
| SECONDARY Percentage Change From Baseline in VAS Sleep Score |
-29.40; -19.74; 2.73; -29.98; -30.85 | — |
Eligibility Criteria
Inclusion Criteria
- Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
- Investigator Global Assessments (IGA) score of 2 or 3
- Body Mass Index (BMI) = 18 - 35 kg/m^2
- Negative Pregnancy test for females
Exclusion Criteria
- Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
- Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
- Major surgery within 3 months of Screening
- Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
- Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing
Data sourced from ClinicalTrials.gov (NCT02655679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.