Trial Outcomes & Findings for Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis (NCT NCT03250624)

Last Updated: 2023-05-01

Results Overview

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Baseline, Day 43

Results posted on

2023-05-01

Participant Flow

The study was conducted at 5 centers in Canada between 01 November 2016 and 26 June 2017.

A total of 101 participants were screened in the study. Out of which, 63 participants were randomized in a ratio of 1:1 to receive CD5024 0.3 percent (%) cream or its vehicle. Screen failures were mainly due to exclusion criteria met.

Participant milestones

Participant milestones
Measure	CD5024 0.3% Cream Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeters square (mg/cm\^2) once daily for 6 weeks.	Placebo Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Overall Study STARTED	32	31
Overall Study COMPLETED	30	24
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Reasons for withdrawal
Measure	CD5024 0.3% Cream Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeters square (mg/cm\^2) once daily for 6 weeks.	Placebo Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Overall Study Lack of Efficacy	1	4
Overall Study Adverse Event	0	1
Overall Study Other	1	2

Baseline Characteristics

Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CD5024 0.3% Cream n=32 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=31 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Total n=63 Participants Total of all reporting groups
Age, Continuous	27.2 years STANDARD_DEVIATION 9.19 • n=39 Participants	30.0 years STANDARD_DEVIATION 10.77 • n=41 Participants	28.6 years STANDARD_DEVIATION 9.98 • n=35 Participants
Sex: Female, Male Female	21 Participants n=39 Participants	26 Participants n=41 Participants	47 Participants n=35 Participants
Sex: Female, Male Male	11 Participants n=39 Participants	5 Participants n=41 Participants	16 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	5 Participants n=39 Participants	3 Participants n=41 Participants	8 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants	5 Participants n=41 Participants	6 Participants n=35 Participants
Race (NIH/OMB) White	25 Participants n=39 Participants	23 Participants n=41 Participants	48 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants
Eczema Area and Severity Index (EASI) Score	5.341 score on a scale STANDARD_DEVIATION 2.432 • n=39 Participants	5.371 score on a scale STANDARD_DEVIATION 2.652 • n=41 Participants	5.356 score on a scale STANDARD_DEVIATION 2.542 • n=35 Participants

PRIMARY outcome

Timeframe: Baseline, Day 43

Population: The Intent-to-treat (ITT) efficacy analysis set was defined as any participant who were randomized.

Outcome measures

Outcome measures
Measure	CD5024 0.3% Cream n=32 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=31 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43	-2.64 score on a scale Standard Error 0.41	-2.36 score on a scale Standard Error 0.44

SECONDARY outcome

Timeframe: Baseline, Days 8,15, 22, 29, 36 and 43

Population: The ITT efficacy analysis set was defined as any participant who were randomized.

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	CD5024 0.3% Cream n=32 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=31 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Percent Change From Baseline in EASI at Each Visit Day 8	-8.7 percent change Standard Deviation 19.1	-5.5 percent change Standard Deviation 39.6
Percent Change From Baseline in EASI at Each Visit Day 15	-21.0 percent change Standard Deviation 37.5	-10.7 percent change Standard Deviation 43.7
Percent Change From Baseline in EASI at Each Visit Day 22	-29.1 percent change Standard Deviation 40.7	-26.7 percent change Standard Deviation 35.8
Percent Change From Baseline in EASI at Each Visit Day 29	-34.5 percent change Standard Deviation 59.9	-21.0 percent change Standard Deviation 41.7
Percent Change From Baseline in EASI at Each Visit Day 36	-43.1 percent change Standard Deviation 35.3	-28.8 percent change Standard Deviation 44.7
Percent Change From Baseline in EASI at Each Visit Day 43	-46.4 percent change Standard Deviation 38.8	-24.6 percent change Standard Deviation 62.7

SECONDARY outcome

Timeframe: Days 8, 15, 22, 29, 36 and 43

Population: The ITT efficacy analysis set was defined as any participant who were randomized.

IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	CD5024 0.3% Cream n=32 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=31 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) Day 8	0 percentage of participants	3.23 percentage of participants
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) Day 15	3.13 percentage of participants	6.45 percentage of participants
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) Day 22	9.38 percentage of participants	9.68 percentage of participants
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) Day 29	15.6 percentage of participants	6.45 percentage of participants
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) Day 36	21.9 percentage of participants	16.1 percentage of participants
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) Day 43	37.5 percentage of participants	9.68 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 36 and 43

Population: The ITT efficacy analysis set was defined as any participant who were randomized.

The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	CD5024 0.3% Cream n=32 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=31 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit Day 8	-15.35 percent change Standard Error 4.51	-17.30 percent change Standard Error 4.75
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit Day 15	-27.94 percent change Standard Error 5.76	-20.82 percent change Standard Error 6.07
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit Day 22	-29.38 percent change Standard Error 6.23	-33.57 percent change Standard Error 6.57
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit Day 29	-37.23 percent change Standard Error 6.64	-34.44 percent change Standard Error 6.99
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit Day 36	-45.01 percent change Standard Error 6.75	42.24 percent change Standard Error 7.11
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit Day 43	-47.63 percent change Standard Error 7.30	-45.00 percent change Standard Error 7.69

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 36 and 43

Population: The ITT efficacy analysis set was defined as any participant who were randomized.

SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	CD5024 0.3% Cream n=32 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=31 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit Day 8	-16.28 percent change Standard Error 4.29	-16.00 percent change Standard Error 4.52
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit Day 15	-30.76 percent change Standard Error 5.51	-20.49 percent change Standard Error 5.81
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit Day 22	-32.02 percent change Standard Error 5.84	-30.73 percent change Standard Error 6.16
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit Day 29	-39.14 percent change Standard Error 6.51	-31.81 percent change Standard Error 6.86
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit Day 36	-46.38 percent change Standard Error 6.67	-40.10 percent change Standard Error 7.03
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit Day 43	-48.92 percent change Standard Error 7.26	-41.48 percent change Standard Error 7.65

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5 and 6

Population: The ITT efficacy analysis set was defined as any participant who were randomized. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	CD5024 0.3% Cream n=31 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=29 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit Week 1	-0.2 score on a scale Standard Deviation 1.1	-0.2 score on a scale Standard Deviation 1.4
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit Week 2	-0.6 score on a scale Standard Deviation 1.9	-0.3 score on a scale Standard Deviation 1.7
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit Week 3	-0.7 score on a scale Standard Deviation 2.1	-0.4 score on a scale Standard Deviation 1.9
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit Week 4	-1.0 score on a scale Standard Deviation 2.3	-0.3 score on a scale Standard Deviation 2.1
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit Week 5	-1.0 score on a scale Standard Deviation 2.2	-0.5 score on a scale Standard Deviation 2.0
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit Week 6	-1.3 score on a scale Standard Deviation 2.4	-0.6 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline, Day 43

Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	CD5024 0.3% Cream n=26 Participants Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=24 Participants Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43	-.31 score on a scale Standard Deviation 0.79	-.13 score on a scale Standard Deviation 0.74

Adverse Events

CD5024 0.3% Cream

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CD5024 0.3% Cream n=32 participants at risk Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.	Placebo n=31 participants at risk Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Infections and infestations Nasopharyngitis	18.8% 6/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	32.3% 10/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Upper respiratory tract infection	6.2% 2/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Folliculitis	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Furuncle	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Gastroenteritis	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Hordeolum	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Tooth abscess	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Viral upper respiratory tract infection	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Urinary tract infection	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Infections and infestations Tinea cruris	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Injury, poisoning and procedural complications Burns first degree	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Injury, poisoning and procedural complications Laceration	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Injury, poisoning and procedural complications Post procedural inflammation	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Injury, poisoning and procedural complications Face injury	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Injury, poisoning and procedural complications Joint injury	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Gastrointestinal disorders Food poisoning	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Gastrointestinal disorders Toothache	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Gastrointestinal disorders Abdominal pain	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	6.5% 2/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Gastrointestinal disorders Constipation	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Gastrointestinal disorders Nausea	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Musculoskeletal and connective tissue disorders Back pain	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Musculoskeletal and connective tissue disorders Pain in extremity	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	6.5% 2/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Nervous system disorders Headache	6.2% 2/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Nervous system disorders Migraine	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Nervous system disorders Presyncope	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Skin and subcutaneous tissue disorders Dermatitis atopic	6.2% 2/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	6.5% 2/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Skin and subcutaneous tissue disorders Skin burning sensation	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Skin and subcutaneous tissue disorders Skin irritation	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Blood and lymphatic system disorders Lymphadenopathy	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Eye disorders Eyelid pain	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Eye disorders Blepharitis	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Renal and urinary disorders Urinary tract infection	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Vascular disorders Hypertension	3.1% 1/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	0.00% 0/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	6.5% 2/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
General disorders Vessel puncture site bruise	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Immune system disorders Seasonal allergy	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Investigations Blood pressure increased	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/32 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.	3.2% 1/31 • Up to Week 9 The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.