Trial Outcomes & Findings for A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas (NCT NCT01007591)

Last Updated: 2025-03-07

Results Overview

PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula: 0.05 (R+T+S) E It ranged from 0 to 3.6.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

From baseline (Day 0) to end of treatment (Week 8)

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	LEO 80190 Ointment LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment Hydrocortisone: Applied once daily
Overall Study STARTED	27	13
Overall Study COMPLETED	26	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 80190 Ointment n=27 Participants LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment n=13 Participants Hydrocortisone: Applied once daily	Total n=40 Participants Total of all reporting groups
Age, Customized Years · 6-8	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Customized Years · 9-11	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Customized Years · 12-14	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Customized Years · 15-17	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	7 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment Canada	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment France	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Germany	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline (Day 0) to end of treatment (Week 8)

Outcome measures

Outcome measures
Measure	LEO 80190 Ointment n=27 Participants LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment n=13 Participants Hydrocortisone: Applied once daily
The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment	-60.8 percentage of change in PASI Standard Deviation 51.1	-54.2 percentage of change in PASI Standard Deviation 59.2

SECONDARY outcome

Timeframe: At end of treatment (Week 8)

For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of the face. For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of the face. At baseline (Day 0) to end of treatment (Week 8) the (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below. Clear, almost clear, mild, moderate, severe and very severe.

Outcome measures

Outcome measures
Measure	LEO 80190 Ointment n=27 Participants LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment n=13 Participants Hydrocortisone: Applied once daily
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF Controlled	13 Participants	7 Participants
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF Non-controlled	14 Participants	6 Participants

SECONDARY outcome

Timeframe: From baseline (Day 0) to Week 4 (Day 28)

Outcome measures

Outcome measures
Measure	LEO 80190 Ointment n=27 Participants LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment n=13 Participants Hydrocortisone: Applied once daily
The Percentage Change in PASI of the Face LOCF at Week 4	-54.8 percentage of change in PASI Standard Deviation 33.8	-54.9 percentage of change in PASI Standard Deviation 37.3

SECONDARY outcome

Timeframe: At end of treatment (Week 8)

Population: The intertriginous analysis set consisted of all participants having 'Mild' or worse according to IGA of the intertriginous areas at baseline. The intertriginous analysis set therefore consisted of 11 participants.

At baseline (Day 0) to end of treatment (Week 8) the (sub)investigator made an assessment of the disease severity of the intertriginous areas using the following 6-category scale. Clear, almost clear, mild, moderate, severe and very severe. For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of the intertriginous areas. For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of the intertriginous areas.

Outcome measures

Outcome measures
Measure	LEO 80190 Ointment n=7 Participants LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment n=4 Participants Hydrocortisone: Applied once daily
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF Controlled	2 Participants	4 Participants
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF Non-controlled	5 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline (Day 0) to end of treatment (Week 8)

For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the intertriginous areas was determined according to the scale below: Redness 0.none 1. mild 2. moderate 3. severe 4. very severe Thickness 0.none 1. mild 2. moderate 3. severe 4. very severe Scaliness 0.none 1. mild 2. moderate 3. severe 4. very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS ranging from 0 to 12.

Outcome measures

Outcome measures
Measure	LEO 80190 Ointment n=7 Participants LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment n=4 Participants Hydrocortisone: Applied once daily
The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF	-56.6 percentage in TSS Standard Deviation 38.2	-93.2 percentage in TSS Standard Deviation 8.2

Adverse Events

LEO 80190 Ointment

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Hydrocortisone 10 mg/g Ointment

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	LEO 80190 Ointment n=27 participants at risk LEO 80190: Applied once daily	Hydrocortisone 10 mg/g Ointment n=13 participants at risk Hydrocortisone: Applied once daily
Ear and labyrinth disorders Ear pain	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Eye disorders Conjunctivitis	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	7.7% 1/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Gastrointestinal disorders Abdominal pain	7.4% 2/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Gastrointestinal disorders Abdominal pain upper	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Gastrointestinal disorders Nausea	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
General disorders Application site burning	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
General disorders Influenza like illness	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
General disorders Pyrexia	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Acute tonsillitis	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Bladder infection	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Bronchitis	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Gastroenteritis	7.4% 2/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Herpes simplex	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Influenza	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	15.4% 2/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Nasopharyngitis	18.5% 5/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	15.4% 2/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Pharyngitis streptococcal	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Infections and infestations Tonsillitis	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Injury, poisoning and procedural complications Joint sprain	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	7.7% 1/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Nervous system disorders Headache	11.1% 3/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	7.7% 1/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Reproductive system and breast disorders Dysmenorrhoea	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Reproductive system and breast disorders Pruritus genital	0.00% 0/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	7.7% 1/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	11.1% 3/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	15.4% 2/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Skin and subcutaneous tissue disorders Erythema	7.4% 2/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Skin and subcutaneous tissue disorders Nail dystrophy	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Skin and subcutaneous tissue disorders Psoriasis	11.1% 3/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Skin and subcutaneous tissue disorders Rash scaly	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Skin and subcutaneous tissue disorders Skin burning sensation	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Skin and subcutaneous tissue disorders Skin irritation	3.7% 1/27 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.	0.00% 0/13 • From baseline (Day 0) to follow-up Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.