Topical Aprepitant in Prurigo Patients
- Registration Number
- NCT01963793
- Lead Sponsor
- LEO Pharma
- Brief Summary
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description aprepitant (left) / placebo (right) Placebo aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body) placebo (left) / aprepitant (right) Placebo placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body) placebo (left) / aprepitant (right) Aprepitant placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body) aprepitant (left) / placebo (right) Aprepitant aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)
- Primary Outcome Measures
Name Time Method Pruritus by VAS (Visual Analogue Scale) 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 Outcome Measures
Name Time Method Pruritus by VAS (Visual Analogue Scale) 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.
Change From Baseline in Participants' Global Assessment on Treatment Areas 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.
Lesional Erythema by Mexameter 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.Transepidermal Water Loss (TEWL) 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.Non-lesional Erythema by Mexameter 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.Clinical Score Assessment of Crusting 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
1. = mild
2. = moderate
3. = severe
The score will be an integer on the scale 0-3.Clinical Score Assessment of Scratch Artefacts 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
1. = mild
2. = moderate
3. = severe
The score will be an integer on the scale 0-3.Melanin by Mexameter 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.Non-lesional Melanin by Mexameter 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.Daily Assessments of Duration of Pruritus (Preceding 12 Hours) 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.Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment 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.
Daily Assessments of Average Pruritus by Use of a VAS 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.Clinical Score Assessment of Erythema 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
1. = mild
2. = moderate
3. = severe
The score will be an integer on the scale 0-3.Clinical Score Assessment of Infiltration 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
1. = mild
2. = moderate
3. = severe
The score will be an integer on the scale 0-3.Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS 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.
Trial Locations
- Locations (1)
Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany