Trial · NCT01963793

Topical Aprepitant in Prurigo Patients

NCT01963793, Phase 2, Completed, LEO Pharma; results first posted 2021-07-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Topical Aprepitant in Prurigo Patients. Trials, record NCT01963793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01963793

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Topical Aprepitant in Prurigo Patients
NCT number: NCT01963793
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: LEO Pharma
Conditions: Pruritus
Interventions: Aprepitant, Placebo
First posted: 2013-10-16
Last updated: 2025-03-10
Results first posted: 2021-07-16

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Pruritus by VAS (Visual Analogue Scale)	At end of treatment (Day 28)	mm	LEAST_SQUARES_MEAN
SECONDARY	Pruritus by VAS (Visual Analogue Scale)	At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42	mm	MEAN
SECONDARY	Change From Baseline in Participants' Global Assessment on Treatment Areas	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	units on a scale	MEAN
SECONDARY	Clinical Score Assessment of Crusting	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	units on a scale	MEAN
SECONDARY	Clinical Score Assessment of Erythema	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	units on a scale	MEAN
SECONDARY	Clinical Score Assessment of Scratch Artefacts	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	units on a scale	MEAN
SECONDARY	Clinical Score Assessment of Infiltration	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	units on a scale	MEAN
SECONDARY	Transepidermal Water Loss (TEWL)	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	g/cm² per hour	MEAN
SECONDARY	Lesional Erythema by Mexameter	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	units on a scale	MEAN
SECONDARY	Non-lesional Erythema by Mexameter	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42	units on a scale	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group476

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pruritus by VAS (Visual Analogue Scale)	Aprepitant 10 mg/g Gel		19.7	95% Confidence Interval 9.5 to 29.8	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant Gel Vehicle		21.2	95% Confidence Interval 11.1 to 31.4	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant 10 mg/g Gel	Day 1 (Visit 2)	50.8	Standard Deviation 26.6	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant Gel Vehicle	Day 1 (Visit 2)	58.1	Standard Deviation 28.2	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant 10 mg/g Gel	Day 14 (Visit 3)	27.1	Standard Deviation 24.2	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant Gel Vehicle	Day 14 (Visit 3)	28.7	Standard Deviation 19.1	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant 10 mg/g Gel	Day 28 (Visit 4)	19.0	Standard Deviation 21.0	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant Gel Vehicle	Day 28 (Visit 4)	21.9	Standard Deviation 24.2	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant 10 mg/g Gel	Day 42 (Visit 5)	23.9	Standard Deviation 28.2	mm
Pruritus by VAS (Visual Analogue Scale)	Aprepitant Gel Vehicle	Day 42 (Visit 5)	24.0	Standard Deviation 26.7	mm

1 to 10 of 476Source ClinicalTrials.gov

See all 476 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aprepitant Gel / Aprepitant Gel Vehicle	20
Overall Study	COMPLETED	Aprepitant Gel / Aprepitant Gel Vehicle	20
Overall Study	NOT COMPLETED	Aprepitant Gel / Aprepitant Gel Vehicle	0

Source ClinicalTrials.gov

Adverse events93

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Visual impairment	Eye disorders	Treatment Not Defined	1	20
other	Visual impairment	Eye disorders	Aprepitant Gel Vehicle	0	20
other	Visual impairment	Eye disorders	Aprepitant Gel	0	20
other	Application site discolouration	General disorders	Treatment Not Defined	0	20
other	Application site discolouration	General disorders	Aprepitant Gel Vehicle	0	20
other	Application site discolouration	General disorders	Aprepitant Gel	1	20
other	Application site discomfort	General disorders	Treatment Not Defined	0	20
other	Application site discomfort	General disorders	Aprepitant Gel Vehicle	2	20
other	Application site discomfort	General disorders	Aprepitant Gel	4	20
other	Application site erythema	General disorders	Treatment Not Defined	0	20

1 to 10 of 93Source ClinicalTrials.gov

See all 93 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment Not Defined	0	20
Total, all-cause mortality	Aprepitant Gel Vehicle	0	20
Total, all-cause mortality	Aprepitant Gel	0	20
Total, other adverse events	Treatment Not Defined	10	20
Total, other adverse events	Aprepitant Gel Vehicle	15	20
Total, other adverse events	Aprepitant Gel	11	20
Total, serious adverse events	Treatment Not Defined	0	20
Total, serious adverse events	Aprepitant Gel Vehicle	0	20
Total, serious adverse events	Aprepitant Gel	0	20

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01963793

GET https://conductscience.org/api/trials/v1/NCT01963793/results?page=2

API reference For AI assistants