Skip to main content
OpenTrials
Completed

NCT Number: NCT01963793

Topical Aprepitant in Prurigo Patients

Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin

Berlin, D-10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aprepitant

Drug

Aprepitant gel (10 mg/g)

Other names: Aprepitant gel

Placebo

Drug

gel without active component

Other names: aprepitant gel vehicle

Primary outcomes

  1. Pruritus by VAS (Visual Analogue Scale)

    Time frame: At end of treatment (Day 28)

    At end of treatment (Day 28) participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

Secondary outcomes

  1. Pruritus by VAS (Visual Analogue Scale)

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42

    At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

  2. Change From Baseline in Participants' Global Assessment on Treatment Areas

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed their prurigo on each treated area using the following score: 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. The change was calculated as the value at the later time point minus the value at baseline. The change at Day 1 was therefore 0 and negative values represent a decrease in score.

  3. Clinical Score Assessment of Crusting

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The (sub)investigator assessed the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:

    Criteria:

    Crusts

    Evaluation:

    0 = not existing

    • = mild
    • = moderate
    • = severe

    The score will be an integer on the scale 0-3.

  4. Clinical Score Assessment of Erythema

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:

    Criteria:

    Erythema

    Evaluation:

    0 = not existing

    • = mild
    • = moderate
    • = severe

    The score will be an integer on the scale 0-3.

  5. Clinical Score Assessment of Scratch Artefacts

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:

    Criteria:

    Scratch artefacts: Superficial damage to the skin caused by severe scratching.

    Evaluation:

    0 = not existing

    • = mild
    • = moderate
    • = severe

    The score will be an integer on the scale 0-3.

  6. Clinical Score Assessment of Infiltration

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:

    Criteria:

    Infiltration

    Evaluation:

    0 = not existing

    • = mild
    • = moderate
    • = severe

    The score will be an integer on the scale 0-3.

  7. Transepidermal Water Loss (TEWL)

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The (sub)investigator will made the following clinical assessment:

    Transepidermal water loss was defined as amount of released water from skin surface in g/cm^2 per hour. The TEWL is increased in case of damage of skin barrier.

  8. Lesional Erythema by Mexameter

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties.

    Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

  9. Non-lesional Erythema by Mexameter

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties.

    Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

  10. Melanin by Mexameter

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties.

    Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

  11. Non-lesional Melanin by Mexameter

    Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

    The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties.

    Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

  12. Daily Assessments of Duration of Pruritus (Preceding 12 Hours)

    Time frame: From baseline to Day 31

    During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the number of hours with pruritus within the last 12 hours on both areas by use of a 7-point scale (<0.5 hours, 0.5-1 hours, 1-2 hours, 3-4 hours, 5-6 hours, 7-8 hours, 9-12 hours).

    Duration of pruritus was categorized as follows: 1 if <0.5 hours, 2 if 0.5-1 hours, 3 if 1-2 hours, 4 if 3-4 hours, 5 if 5-6 hours, 6 if 7-8 hours and 7 if 9-12 hours.

    The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.

  13. Daily Assessments of Average Pruritus by Use of a VAS

    Time frame: From baseline to Day 31

    During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the average intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

    The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1, before cream was applied.

  14. Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS

    Time frame: From baseline to Day 31

    During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the maximum intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

    The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.

  15. Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment

    Time frame: Day 28

    On the last day of treatment, participants assessed the change of pruritus compared to baseline in percentage by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Acronym: iTAPP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 16, 2013
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.