Trial Outcomes & Findings for Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris. (NCT NCT02073448)
NCT ID: NCT02073448
Last Updated: 2017-03-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
417 participants
Primary outcome timeframe
Baseline - Week12
Results posted on
2017-03-28
Participant Flow
Participant milestones
| Measure |
CD0271
Adapalene 01% Gel
CD0271
|
GK530G
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Overall Study
STARTED
|
101
|
212
|
104
|
|
Overall Study
COMPLETED
|
99
|
200
|
99
|
|
Overall Study
NOT COMPLETED
|
2
|
12
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
Baseline characteristics by cohort
| Measure |
GK530G
n=212 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD0271
n=101 Participants
Adapalene 01% Gel
CD0271
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
Total
n=417 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
116 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
228 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
189 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
19.7 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
19.6 years
STANDARD_DEVIATION 6.0 • n=107 Participants
|
19.3 years
STANDARD_DEVIATION 5.4 • n=206 Participants
|
19.6 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
282 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
135 Participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
212 participants
n=99 Participants
|
101 participants
n=107 Participants
|
104 participants
n=206 Participants
|
417 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week12Outcome measures
| Measure |
CD0271
n=101 Participants
Adapalene 01% Gel
CD0271
|
GK530G
n=212 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Percent Changes From Baseline in Total Lesion Counts
|
68.6 percent change
Interval -62.4 to 97.5
|
82.7 percent change
Interval -15.9 to 100.0
|
81.6 percent change
Interval -31.6 to 98.6
|
SECONDARY outcome
Timeframe: up to 12 weeksOutcome measures
| Measure |
CD0271
n=101 Participants
Adapalene 01% Gel
CD0271
|
GK530G
n=212 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Percent of Subjects With Adverse Events
|
27.7 percentage of participants
|
44.8 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD0271
n=212 Participants
Adapalene 01% Gel
CD0271
|
GK530G
n=101 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Local Tolerability (Erythema)
Severe
|
2 participants
|
0 participants
|
1 participants
|
|
Local Tolerability (Erythema)
Mild
|
78 participants
|
32 participants
|
20 participants
|
|
Local Tolerability (Erythema)
Moderate
|
24 participants
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD0271
n=212 Participants
Adapalene 01% Gel
CD0271
|
GK530G
n=101 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Local Tolerability (Scaling)
Mild
|
105 participants
|
37 participants
|
24 participants
|
|
Local Tolerability (Scaling)
Moderate
|
33 participants
|
9 participants
|
3 participants
|
|
Local Tolerability (Scaling)
Severe
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD0271
n=212 Participants
Adapalene 01% Gel
CD0271
|
GK530G
n=101 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Local Tolerability (Dryness)
Mild
|
113 participants
|
44 participants
|
29 participants
|
|
Local Tolerability (Dryness)
Moderate
|
31 participants
|
6 participants
|
4 participants
|
|
Local Tolerability (Dryness)
Severe
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD0271
n=212 Participants
Adapalene 01% Gel
CD0271
|
GK530G
n=101 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Local Tolerability (Pruritus)
Mild
|
61 participants
|
24 participants
|
24 participants
|
|
Local Tolerability (Pruritus)
Moderate
|
21 participants
|
2 participants
|
9 participants
|
|
Local Tolerability (Pruritus)
Severe
|
3 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD0271
n=212 Participants
Adapalene 01% Gel
CD0271
|
GK530G
n=101 Participants
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 Participants
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Local Tolerability (Stinging/Burning)
Mild
|
106 participants
|
49 participants
|
21 participants
|
|
Local Tolerability (Stinging/Burning)
Moderate
|
76 participants
|
11 participants
|
9 participants
|
|
Local Tolerability (Stinging/Burning)
Severe
|
7 participants
|
2 participants
|
1 participants
|
Adverse Events
CD0271
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
GK530G
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
CD1579
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CD0271
n=101 participants at risk
Adapalene 01% Gel
CD0271
|
GK530G
n=212 participants at risk
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
|
CD1579
n=104 participants at risk
Benzoyl Peroxide 2.5% Gel
CD1579
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/101 • 12 weeks
|
1.9%
4/212 • Number of events 4 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
7/101 • Number of events 7 • 12 weeks
|
8.5%
18/212 • Number of events 18 • 12 weeks
|
13.5%
14/104 • Number of events 15 • 12 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/101 • 12 weeks
|
1.9%
4/212 • Number of events 4 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/101 • 12 weeks
|
1.9%
4/212 • Number of events 4 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
2.4%
5/212 • Number of events 5 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/101 • 12 weeks
|
1.4%
3/212 • Number of events 5 • 12 weeks
|
2.9%
3/104 • Number of events 4 • 12 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.0%
3/101 • Number of events 4 • 12 weeks
|
2.4%
5/212 • Number of events 5 • 12 weeks
|
3.8%
4/104 • Number of events 5 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
6.9%
7/101 • Number of events 7 • 12 weeks
|
12.3%
26/212 • Number of events 27 • 12 weeks
|
4.8%
5/104 • Number of events 5 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
5/101 • Number of events 5 • 12 weeks
|
3.3%
7/212 • Number of events 7 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
1.4%
3/212 • Number of events 3 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
1.4%
3/212 • Number of events 4 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Eye disorders
Eye pruritus
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
General disorders
Pyrexia
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
General disorders
Fatigue
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Body tinea
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Bronchitis
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Furuncle
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Hordeolum
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Influenza
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Oral herpes
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
2/101 • Number of events 2 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Investigations
Skin test positive
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Investigations
White blood cell count increased
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis perennial
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/101 • 12 weeks
|
0.94%
2/212 • Number of events 2 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.99%
1/101 • Number of events 1 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
1.9%
2/104 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
1.9%
2/104 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/101 • 12 weeks
|
0.47%
1/212 • Number of events 1 • 12 weeks
|
0.00%
0/104 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/101 • 12 weeks
|
0.00%
0/212 • 12 weeks
|
0.96%
1/104 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place