NCT04676763 is a NA clinical trial of Substance P in Skin Diseases, sponsored by GlaxoSmithKline.

Who is sponsoring NCT04676763?

NCT04676763 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT04676763?

Interventions in NCT04676763: Substance P, Normal Saline, Histamine.

What condition does NCT04676763 study?

NCT04676763 studies Skin Diseases.

Is NCT04676763 still recruiting?

NCT04676763 is currently completed. Last updated 20 January 2025.

Are results published for NCT04676763?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-20 · How we verify

NCT04676763

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Substance P Challenge in Healthy Participants

Completed NA Results posted Last updated 20 January 2025

What this trial tests

NA trial testing Substance P in Skin Diseases in 32 participants. Completed in 21 July 2021.

Timeline

2 March 2021

Primary endpoint
21 July 2021

21 July 2021

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	32
Start date	2 March 2021
Primary completion	21 July 2021
Estimated completion	21 July 2021
Sites	1 location across Netherlands

Drugs / interventions tested

Substance P — full drug profile →
Normal Saline
Histamine (HISTAMINE) — full drug profile →

Conditions studied

Skin Diseases — all drugs for Skin Diseases →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 50, any sex, with Skin Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) Primary · 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1)

Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P (SP) was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 picomoles (pmol) during the 2 hours post-challenge period.

Saline

Group	Value	95% CI
Part 1- Skin Challenges	155.2379	± 97.43852

Histamine

Group	Value	95% CI
Part 1- Skin Challenges	2151.2320	± 1352.66124

SP 5 pmol

Group	Value	95% CI
Part 1- Skin Challenges	2749.0997	± 2000.66201

SP 15 pmol

Group	Value	95% CI
Part 1- Skin Challenges	5727.2220	± 3859.78704

SP 50 pmol

Group	Value	95% CI
Part 1- Skin Challenges	7111.5570	± 5388.48885

SP 150 pmol

Group	Value	95% CI
Part 1- Skin Challenges	8295.6310	± 5912.58152

SP 500 pmol

Group	Value	95% CI
Part 1- Skin Challenges	12540.9840	± 14705.68961

Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) Primary · 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2)

Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.

Saline: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	157.9157	± 110.11185

Saline: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	216.5196	± 113.81519

Histamine: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	2617.3622	± 1362.88319

Histamine: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	2486.9477	± 1171.55762

SP 5 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	4534.4513	± 2153.69897

SP 5 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	4563.5113	± 2517.52789

SP 15 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	6754.7067	± 3501.44122

SP 15 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	6506.0915	± 3199.02966

Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) Secondary · 2 hours post-challenge on Day 1 (Visit 1)

Wheal area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.

Saline

Group	Value	95% CI
Part 1- Skin Challenges	15.2152	± 8.97791

Histamine

Group	Value	95% CI
Part 1- Skin Challenges	44.5782	± 16.73404

SP 5 pmol

Group	Value	95% CI
Part 1- Skin Challenges	42.4284	± 20.26132

SP 15 pmol

Group	Value	95% CI
Part 1- Skin Challenges	82.7571	± 41.76154

SP 50 pmol

Group	Value	95% CI
Part 1- Skin Challenges	99.8398	± 48.06381

SP 150 pmol

Group	Value	95% CI
Part 1- Skin Challenges	126.1186	± 55.28040

SP 500 pmol

Group	Value	95% CI
Part 1- Skin Challenges	194.0748	± 178.88175

Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) Secondary · 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2)

Wheal area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.

Saline : 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	16.6335	± 11.36559

Saline: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	21.7610	± 12.79723

Histamine: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	53.1929	± 26.57857

Histamine: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	52.8665	± 16.31003

SP 5 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	85.8111	± 23.45193

SP 5 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	92.1595	± 24.44909

SP 15 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	112.9690	± 30.79242

SP 15 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	113.0940	± 26.92327

Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) Secondary · 2 hours post-challenge on Day 1 (Visit 1)

Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.

Saline

Group	Value	95% CI
Part 1- Skin Challenges	5.0	5 – 11

Histamine

Group	Value	95% CI
Part 1- Skin Challenges	20.0	15 – 42

SP 5 pmol

Group	Value	95% CI
Part 1- Skin Challenges	20.0	5 – 60

SP 15 pmol

Group	Value	95% CI
Part 1- Skin Challenges	20.0	10 – 40

SP 50 pmol

Group	Value	95% CI
Part 1- Skin Challenges	17.5	10 – 21

SP 150 pmol

Group	Value	95% CI
Part 1- Skin Challenges	20.0	10 – 60

SP 500 pmol

Group	Value	95% CI
Part 1- Skin Challenges	20.0	5 – 20

Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) Secondary · 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2)

Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.

Saline : 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	5.0	4 – 10

Saline: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	5.0	4 – 10

Histamine: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	30.0	9 – 62

Histamine: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	24.5	14 – 60

SP 5 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	18.5	9 – 39

SP 5 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	19.0	9 – 39

SP 15 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	19.5	8 – 90

SP 15 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	18.5	11 – 89

Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) Secondary · 2 hours post-challenge on Day 1 (Visit 1)

Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.

Saline

Group	Value	95% CI
Part 1- Skin Challenges	39.0	15 – 55

Histamine

Group	Value	95% CI
Part 1- Skin Challenges	90.0	56 – 93

SP 5 pmol

Group	Value	95% CI
Part 1- Skin Challenges	62.0	40 – 120

SP 15 pmol

Group	Value	95% CI
Part 1- Skin Challenges	120.0	42 – 121

SP 50 pmol

Group	Value	95% CI
Part 1- Skin Challenges	74.5	59 – 90

SP 150 pmol

Group	Value	95% CI
Part 1- Skin Challenges	75.5	40 – 120

SP 500 pmol

Group	Value	95% CI
Part 1- Skin Challenges	104.5	60 – 120

Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) Secondary · 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2)

Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.

Saline : 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	16.0	11 – 30

Saline: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	20.0	11 – 27

Histamine: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	90.5	6 – 120

Histamine: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	90.0	40 – 120

SP 5 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	89.0	38 – 121

SP 5 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	61.0	58 – 121

SP 15 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	90.0	38 – 121

SP 15 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	88.0	40 – 123

Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) Secondary · 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1)

Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.

Saline

Group	Value	95% CI
Part 1- Skin Challenges	0.0000	± 0.00000

Histamine

Group	Value	95% CI
Part 1- Skin Challenges	47977.8047	± 35779.56892

SP 5 pmol

Group	Value	95% CI
Part 1- Skin Challenges	8232.5351	± 10307.53738

SP 15 pmol

Group	Value	95% CI
Part 1- Skin Challenges	26562.8609	± 22150.49500

SP 50 pmol

Group	Value	95% CI
Part 1- Skin Challenges	53505.6580	± 31081.10933

SP 150 pmol

Group	Value	95% CI
Part 1- Skin Challenges	54407.2697	± 34805.98795

SP 500 pmol

Group	Value	95% CI
Part 1- Skin Challenges	64978.5132	± 67350.94024

Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) Secondary · 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2)

Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response variable was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.

Saline : 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	0.0000	± 0.00000

Saline: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	0.0000	± 0.00000

Histamine: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	42825.0421	± 31599.99246

Histamine: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	50717.6974	± 35294.02927

SP 5 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	20515.8733	± 17779.84450

SP 5 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	30689.5773	± 29415.10538

SP 15 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	48796.3715	± 31253.62644

SP 15 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	52359.5705	± 34531.05693

Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) Secondary · 2 hours post-challenge on Day 1 (Visit 1)

Flare area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.

Saline

Group	Value	95% CI
Part 1- Skin Challenges	0.0000	± 0.00000

Histamine

Group	Value	95% CI
Part 1- Skin Challenges	1209.6224	± 604.47133

SP 5 pmol

Group	Value	95% CI
Part 1- Skin Challenges	619.6359	± 940.26080

SP 15 pmol

Group	Value	95% CI
Part 1- Skin Challenges	1422.8103	± 763.79695

SP 50 pmol

Group	Value	95% CI
Part 1- Skin Challenges	2240.1860	± 971.83781

SP 150 pmol

Group	Value	95% CI
Part 1- Skin Challenges	2282.5890	± 1149.03190

SP 500 pmol

Group	Value	95% CI
Part 1- Skin Challenges	2383.3822	± 1590.27531

Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) Secondary · 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2)

Flare area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.

Saline : 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	0.0000	± 0.00000

Saline: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	0.0000	± 0.00000

Histamine: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	1110.0748	± 514.76131

Histamine: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	1392.6911	± 671.10955

SP 5 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	1035.4156	± 572.41049

SP 5 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	1398.2891	± 1007.58015

SP 15 pmol: 2 hours post-challenge on Day 1

Group	Value	95% CI
Part 2- Skin Challenges	1892.5393	± 791.10820

SP 15 pmol: 2 hours post-challenge at Week 2

Group	Value	95% CI
Part 2- Skin Challenges	1956.0858	± 1018.31529

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality, SAEs and non-serious AEs were collected from the start of study treatment up to Day 1 for Part 1 and Up to Week 3 for Part 2.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1- Skin Challenges

Serious: 0/9 (0%)

Deaths: 0/9

Part 2- Skin Challenges

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (2 terms — click to expand)

Reaction	System	Part 1- Skin Challenges	Part 2- Skin Challenges
Headache	Nervous system disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04676763 adverse events section.

Sponsor's own description

The objectives of this enabling study are to characterize the wheal and flare responses over time following skin challenges with ascending concentrations of Substance P. This will be a 2-part study: Part 1 will aid in the understanding of the wheal and flare responses following Substance P. Part 2 will investigate the variability of the responses. Participants may be enrolled into Part 1 or Part 2, not both.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Intradermal substance P as a challenge agent in healthy individuals.
Ten Voorde W, Akinseye C, Abdisalaam I, Wind S, et al · · 2023 · cited 2× · PMID 37547990 · DOI 10.1111/cts.13592

Verify or expand the search:

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Trials testing the same drug.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04676763 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 20 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04676763.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04676763

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Substance P

Other recruiting trials for Skin Diseases

Other GlaxoSmithKline trials

Verify against primary sources