Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Aprepitant gel (10 mg/g)
gel without active component
Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin
Berlin, Germany
Pruritus by VAS (Visual Analogue Scale)
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.
Time frame: At end of treatment (Day 28)
Pruritus by VAS (Visual Analogue Scale)
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42
Change From Baseline in Participants' Global Assessment on Treatment Areas
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Crusting
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Erythema
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.
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Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Scratch Artefacts
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Infiltration
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Transepidermal Water Loss (TEWL)
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Lesional Erythema by Mexameter
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Non-lesional Erythema by Mexameter
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Melanin by Mexameter
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Non-lesional Melanin by Mexameter
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
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.
Time frame: From baseline to Day 31
Daily Assessments of Average Pruritus by Use of a VAS
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.
Time frame: From baseline to Day 31
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
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.
Time frame: From baseline to Day 31
Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment
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.
Time frame: Day 28