Trial Outcomes & Findings for Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis (NCT NCT01563185)

NCT ID: NCT01563185

Last Updated: 2024-12-16

Results Overview

Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)
• Results posted on: 2024-12-16

Participant Flow

Participant milestones

Measure	DUEXIS 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	DUEXIS 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Overall Study Withdrawal by Subject	1
Overall Study Non-Compliance with study drug	1

Baseline Characteristics

Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis

Baseline characteristics by cohort

Measure	DUEXIS n=12 Participants 800 mg ibuprofen/26.6 mg famotidine 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	13.8 years STANDARD_DEVIATION 1.71 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)

Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.

Outcome measures

Measure	DUEXIS n=12 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE: Nervous system disorders	1 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) Any patient with at least 1 TEAE	12 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) Any patient with at least 1 mild TEAE	7 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) At least 1 moderate TEAE	5 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) At least 1 severe TEAE	0 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) A possibly related TEAE	2 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) SAE	0 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) A TEAE leading to study drug discontinuation	0 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) A TEAE leading to death	0 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE: Gastrointestinal Disorders	4 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE: General disorders	2 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE: Infections and infestations	7 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE: Injury, poisoning & procedural complications	2 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE: Muscoskeletal & connective tissue disorders	2 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE:Respiratory, thoracic & mediastinal disorders	3 participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) TEAE: Skin and subcutaneous tissue disorders	2 participants

SECONDARY outcome

Timeframe: Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

To assess patient quality of life while on study medication, the CHQ was administered to the patients' parent or guardian on Day 0 and at the Week 24/ET visit. The raw scale scores were transformed into scores on a 0 to 100 scale, 100 indicating best health and 0 indicating worst health. The algorithm is:

Transformed Score = ((Actual Raw Score - Lowest Possible Raw Score)/(Possible Raw Score Range)) x100. The actual raw score is the mean of the item responses in a scale (sum of item responses/number of completed items). The possible raw score range is the highest possible raw score minus the lowest possible raw score. The outcome measure data table shows the average change in the CHQ concepts from Baseline to the week 24 visit. The average change in the CHQ concepts is on a -100 to 100 scale, -100 representing a negative change in health and 100 indicating a positive change in health.

Outcome measures

Measure	DUEXIS n=12 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Global Health	2.5 units on a scale Standard Deviation 21.16
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Physical Functioning	19.0 units on a scale Standard Deviation 36.29
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Role/Social Limitations: Emotional/Behavioral	14.8 units on a scale Standard Deviation 35.86
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Role/Social Limitations: Physical	20.8 units on a scale Standard Deviation 32.68
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Bodily Pain/Discomfort	15.8 units on a scale Standard Deviation 27.12
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Behavior	8.4 units on a scale Standard Deviation 13.29
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Global Behavior Item	6.7 units on a scale Standard Deviation 10.30
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Mental Health	3.3 units on a scale Standard Deviation 9.37
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Self Esteem	5.3 units on a scale Standard Deviation 12.47
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores General Health Perceptions	1.9 units on a scale Standard Deviation 14.40
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Change in Health	14.6 units on a scale Standard Deviation 39.11
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Parental Impact: Emotional	20.4 units on a scale Standard Deviation 24.51
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Parental Impact:Time	22.2 units on a scale Standard Deviation 30.92
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Family Activities	14.3 units on a scale Standard Deviation 26.80
Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores Family Cohesion	4.6 units on a scale Standard Deviation 8.65

SECONDARY outcome

Timeframe: Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: the physician's global assessment of disease activity and the parent's global assessment of overall well-being. These ACR values represent the average change in the physician's global assessment of disease activity and the parent's global assessment of overall well-being from the baseline visit to the week 24/ET visit. The ACR pediatric core measure: Physician's global assessment of disease activity and parent's assessment of overall well being was measured on a scale of 0-100 mm (0 = very good, 100=very poor).

Outcome measures

Measure	DUEXIS n=12 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
American College of Rheumatology (ACR) Pediatric Core Measures: Physician's Global Assessment of Disease Activity and Parent's Assessment of Overall Well-being Physician's Global Assessment of Disease Activity	-9.1 units on a scale Standard Error 28.34
American College of Rheumatology (ACR) Pediatric Core Measures: Physician's Global Assessment of Disease Activity and Parent's Assessment of Overall Well-being Parent's Global Assessment of Overall Well-Being	-8.0 units on a scale Standard Error 34.07

SECONDARY outcome

Timeframe: Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CHAQ - Disability Index. This ACR measurement represents the average change in the Childhood Health Assessment Questionnaire (CHAQ) - Disability Index from the baseline visit to the week 24/ET visit. The CHAQ disability index is measured on a scale of 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).

Outcome measures

Measure	DUEXIS n=12 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
American College of Rheumatology (ACR) Pediatric Core Measures: CHAQ - Disability Index	-0.146 units on a scale Standard Error 0.3235

SECONDARY outcome

Timeframe: Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: number of joints with active arthritis and the number of joints with limited range of motion. These ACR values represent the average change in number of joints with active arthritis and the number of joints with limited range of motion from the baseline visit to the week 24/ET visit.

The joints that were assessed include the right and left temporomandibular, sternoclavicular, arcomiclavicular, shoulder, elbow, wrist, MCP - 1. MCP - 2, MCP - 3, MCP - 4, MCP - 5, PIP - 1, PIP - 2, PIP - 3, PIP - 4, PIP - 5, DIP - 1, DIP - 2, DIP - 3, DIP - 4, and DIP - 5.

Outcome measures

Measure	DUEXIS n=12 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
ACR Pediatric Components by Time Point: Number of Joints With Active Arthritis and the Number of Joints With Limited Range of Motion Number of Joints With Active Arthritis Number of joints with active arthritis	-4.3 Number of joints Standard Error 6.97
ACR Pediatric Components by Time Point: Number of Joints With Active Arthritis and the Number of Joints With Limited Range of Motion Number of Joints With Active Arthritis Number of joints with limited range of motion	-1.7 Number of joints Standard Error 5.43

SECONDARY outcome

Timeframe: Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CRP Concentration. This ACR value represents the average change in Serum C Reactive Protein (CRP) Concentration from the baseline visit to the week 24/ET visit. The normal range referenced was 0 mg/L - 4.99 mg/L.

Outcome measures

Measure	DUEXIS n=12 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
American College of Rheumatology (ACR) Pediatric Core Measures: Serum C Reactive Protein (CRP) Concentration	1.019 mg/L Standard Error 3.9742

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 4, 8 hours post-dose

Population: The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).

Tmax was estimated for ibuprofen and famotidine.The PK parameters for ibuprofen and famotidine represent average Tmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.

Outcome measures

Measure	DUEXIS n=3 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Time of Maximum Observed Concentration (Tmax) Tmax: Ibuprofen	1.75 hours Standard Deviation 0.66
Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Time of Maximum Observed Concentration (Tmax) Tmax: Famotidine	2.1 hours Standard Deviation 0.14

SECONDARY outcome

Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose

Population: The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).

Cmax was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average Cmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.

Outcome measures

Measure	DUEXIS n=3 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Maximum Observed Concentration (Cmax) Cmax: Ibuprofen	49.8 ug/mL Standard Deviation 13.7
Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Maximum Observed Concentration (Cmax) Cmax: Famotidine	55.0 ug/mL Standard Deviation 11.9

SECONDARY outcome

Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose

Population: The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 patient was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).

AUC(0-t) was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average AUC values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.

Outcome measures

Measure	DUEXIS n=3 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUC(0-t)) AUC(0-t): Ibuprofen	196.5 ug*h/mL Standard Deviation 27.4
Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUC(0-t)) AUC(0-t): Famotidine	267.6 ug*h/mL Standard Deviation 27.1

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group

Population: The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable and all 9 were in the multiple dose pharmacokinetic group).

CL/F was estimated in ibuprofen and famotidine.

Outcome measures

Measure	DUEXIS n=9 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Individual Oral Clearance (CL/F) CL/F: Ibuprofen	2.8 L/h/70 kg Standard Deviation 0.6
Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Individual Oral Clearance (CL/F) CL/F: Famotidine	61.5 L/h/70 kg Standard Deviation 15.9

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group

V/F were estimated in ibuprofen and famotidine.

Outcome measures

Measure	DUEXIS n=9 Participants 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Volume Distribution (V/F) V/F: Ibuprofen	16.7 L/70 kg Standard Deviation 4.6
Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Volume Distribution (V/F) V/F: Famotidine	564.4 L/70 kg Standard Deviation 154.6

Adverse Events

DUEXIS

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DUEXIS n=12 participants at risk 800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
Gastrointestinal disorders Diarrhoea	16.7% 2/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Gastrointestinal disorders Abdominal pain upper	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Gastrointestinal disorders Constipation	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Gastrointestinal disorders Haematochezia	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Gastrointestinal disorders Nausea	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Gastrointestinal disorders Tooth impacted	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
General disorders Fatigue	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
General disorders Gait disturbance	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Infections and infestations Gastroenteritis viral	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Infections and infestations Oral viral infection	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Infections and infestations Paronychia	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Infections and infestations Sinusitis	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Infections and infestations Tinea pedis	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Infections and infestations Upper respiratory tract infection	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Injury, poisoning and procedural complications Hand fracture	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Injury, poisoning and procedural complications Joint dislocation	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Nervous system disorders Headache	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Skin and subcutaneous tissue disorders Ingrowing nail	16.7% 2/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Skin and subcutaneous tissue disorders Acne	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.
Skin and subcutaneous tissue disorders Dermal cyst	8.3% 1/12 • Adverse events were collected from the Day 0 visit up until the Follow-up visit (Week 26). Adverse events were collected at the following time points: Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 26.

Additional Information

Julie Ball, Senior Director of Clinical Development & Operations

Horizon Pharma

Phone: 224-383-3059

Email: jball@horizonpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60