Phase 2
N=20
Topical Aprepitant in Prurigo Patients
Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT01963793 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Pruritus by VAS (Visual Analogue Scale) — 19.7; 21.2 mm — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aprepitant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pruritus by VAS (Visual Analogue Scale) |
50.8; 58.1; 27.1; 28.7; 19.0; 21.9 | — |
| SECONDARY Pruritus by VAS (Visual Analogue Scale) |
50.8; 58.1; 27.1; 28.7; 19.0; 21.9 | — |
| SECONDARY Change From Baseline in Participants' Global Assessment on Treatment Areas |
0.0; 0.0; -0.5; -0.7; -0.6; -0.7 | — |
| SECONDARY Clinical Score Assessment of Crusting |
1.3; 1.4; 0.9; 1.1; 0.7; 1.0 | — |
| SECONDARY Clinical Score Assessment of Erythema |
2.0; 2.1; 1.8; 1.8; 1.5; 1.7 | — |
| SECONDARY Clinical Score Assessment of Scratch Artefacts |
1.7; 1.8; 1.3; 1.3; 1.1; 1.4 | — |
| SECONDARY Clinical Score Assessment of Infiltration |
1.5; 1.5; 1.3; 1.4; 1.1; 1.3 | — |
| SECONDARY Transepidermal Water Loss (TEWL) |
20.6; 25.2; 22.7; 24.0; 20.0; 19.9 | — |
| SECONDARY Lesional Erythema by Mexameter |
438; 453; 527; 463; 464; 491 | — |
| SECONDARY Non-lesional Erythema by Mexameter |
304; 300; 287; 312; 262; 271 | — |
| SECONDARY Melanin by Mexameter |
131; 115; 121; 134; 152; 139 | — |
| SECONDARY Non-lesional Melanin by Mexameter |
127; 129; 165; 215; 149; 166 | — |
| SECONDARY Daily Assessments of Duration of Pruritus (Preceding 12 Hours) |
3.7; 4.0; NA; NA; 3.5; 3.7 | — |
| SECONDARY Daily Assessments of Average Pruritus by Use of a VAS |
49.1; 51.3; NA; NA; 45.0; 44.7 | — |
| SECONDARY Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS |
61.1; 62.7; NA; NA; 49.9; 54.7 | — |
| SECONDARY Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment |
50.8; 41.7 | — |
Summary
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Eligibility Criteria
Inclusion Criteria
- Patient with Prurigo suffering from chronic pruritus
- Disease duration > six month
- Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation
- Adult male or female patients, aged 18 to 80 years
Exclusion Criteria
- Concomitant medications that are primarily metabolized through Cytochrome P450 3A4
- Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial
- UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)
- Prescribed systemic medications are limited
- Clinically significant abnormalities in Blood analyses
- Anamnestic excessive use of alcohol or tobacco or drugs
- Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)
- Known or suspected hypersensitivity to component(s) of investigational products
- Within the last 30 days or current participation in any other interventional clinical trial
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month
- Previously enrolled/randomised in this clinical trial
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
- Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding
- Females of child-bearing potential with positive pregnancy test
- Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
Data sourced from ClinicalTrials.gov (NCT01963793). 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.