Trial Outcomes & Findings for Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris (NCT NCT05550337)
NCT ID: NCT05550337
Last Updated: 2024-09-26
Results Overview
Mean percent change from screening/baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
807 participants
Primary outcome timeframe
Baseline and 12 Weeks
Results posted on
2024-09-26
Participant Flow
Participant milestones
| Measure |
Test: Trifarotene Cream, 0.005%
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Trifarotene 0.005 % Topical Cream: Cream
|
AKLIEF®
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
AKLIEF®: Cream
|
Vehicle Product
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Placebo: Cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
269
|
269
|
269
|
|
Overall Study
COMPLETED
|
241
|
235
|
241
|
|
Overall Study
NOT COMPLETED
|
28
|
34
|
28
|
Reasons for withdrawal
| Measure |
Test: Trifarotene Cream, 0.005%
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Trifarotene 0.005 % Topical Cream: Cream
|
AKLIEF®
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
AKLIEF®: Cream
|
Vehicle Product
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Placebo: Cream
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
14
|
10
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
3
|
4
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
16
|
11
|
11
|
Baseline Characteristics
Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Test: Trifarotene Cream, 0.005%
n=269 Participants
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Trifarotene 0.005 % Topical Cream: Cream
|
AKLIEF®
n=269 Participants
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
AKLIEF®: Cream
|
Vehicle Product
n=269 Participants
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Placebo: Cream
|
Total
n=807 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23 Years
STANDARD_DEVIATION 7.03 • n=5 Participants
|
22.8 Years
STANDARD_DEVIATION 7.31 • n=7 Participants
|
23.5 Years
STANDARD_DEVIATION 7.24 • n=5 Participants
|
23.1 Years
STANDARD_DEVIATION 7.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
487 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
172 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
535 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
193 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
585 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Baseline IGA Score
0=clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline IGA Score
1=almost clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline IGA Score
2=mild
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Baseline IGA Score
3=moderate
|
184 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
555 Participants
n=4 Participants
|
|
Baseline IGA Score
4=severe
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Per Protocol Population
Mean percent change from screening/baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Outcome measures
| Measure |
Test: Trifarotene Cream, 0.005%
n=225 Participants
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Trifarotene 0.005 % Topical Cream: Cream
|
AKLIEF®
n=196 Participants
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
AKLIEF®: Cream
|
Vehicle Product
n=213 Participants
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Placebo: Cream
|
|---|---|---|---|
|
Primary Change in Inflammatory Lesion Counts
|
-72.86 Percent change
Standard Deviation 33.364
|
-78.83 Percent change
Standard Deviation 23.547
|
-34.12 Percent change
Standard Deviation 38.332
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Per Protocol Population
Mean percent change from screening/baseline to week 12 in the noninflammatory (open and closed comedones) lesion counts.
Outcome measures
| Measure |
Test: Trifarotene Cream, 0.005%
n=225 Participants
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Trifarotene 0.005 % Topical Cream: Cream
|
AKLIEF®
n=196 Participants
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
AKLIEF®: Cream
|
Vehicle Product
n=213 Participants
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Placebo: Cream
|
|---|---|---|---|
|
Primary Change in Non-Inflammatory Lesion Count
|
-62.03 Percent change
Standard Deviation 31.716
|
-67.51 Percent change
Standard Deviation 27.577
|
-27.30 Percent change
Standard Deviation 36.628
|
Adverse Events
Test: Trifarotene Cream, 0.005%
Serious events: 0 serious events
Other events: 23 other events
Deaths: 23 deaths
AKLIEF®
Serious events: 1 serious events
Other events: 37 other events
Deaths: 37 deaths
Vehicle Product
Serious events: 0 serious events
Other events: 18 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Test: Trifarotene Cream, 0.005%
n=269 participants at risk
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Trifarotene 0.005 % Topical Cream: Cream
|
AKLIEF®
n=269 participants at risk
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
AKLIEF®: Cream
|
Vehicle Product
n=269 participants at risk
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Placebo: Cream
|
|---|---|---|---|
|
Reproductive system and breast disorders
Ovarian Torsion
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • Number of events 1 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
Other adverse events
| Measure |
Test: Trifarotene Cream, 0.005%
n=269 participants at risk
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Trifarotene 0.005 % Topical Cream: Cream
|
AKLIEF®
n=269 participants at risk
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
AKLIEF®: Cream
|
Vehicle Product
n=269 participants at risk
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Placebo: Cream
|
|---|---|---|---|
|
General disorders
Application site dryness
|
1.5%
4/269 • 7.5 months
|
1.9%
5/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
General disorders
Application site erythema
|
0.00%
0/269 • 7.5 months
|
1.5%
4/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
General disorders
Application site exfoliation
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
General disorders
Application site pain
|
0.37%
1/269 • 7.5 months
|
0.74%
2/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
General disorders
Chills
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
General disorders
Fatigue
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
General disorders
Pyrexia
|
0.37%
1/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
General disorders
Swelling face
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Gastrointestinal disorders
Nausea
|
0.37%
1/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Gastrointestinal disorders
Vomiting
|
0.37%
1/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/269 • 7.5 months
|
0.74%
2/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Infections and infestations
Abscess limb
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Infections and infestations
COVID-19
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Gastrointestinal disorders
Influenza
|
0.00%
0/269 • 7.5 months
|
0.74%
2/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Gastrointestinal disorders
Nasopharyngitis
|
1.5%
4/269 • 7.5 months
|
1.9%
5/269 • 7.5 months
|
1.1%
3/269 • 7.5 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/269 • 7.5 months
|
0.74%
2/269 • 7.5 months
|
0.74%
2/269 • 7.5 months
|
|
Infections and infestations
Tinea faciei
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.37%
1/269 • 7.5 months
|
1.5%
4/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Nervous system disorders
Headache
|
1.1%
3/269 • 7.5 months
|
1.5%
4/269 • 7.5 months
|
2.2%
6/269 • 7.5 months
|
|
Nervous system disorders
Migraine
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/269 • 7.5 months
|
0.74%
2/269 • 7.5 months
|
1.1%
3/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
3/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
3/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
3/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.74%
2/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.37%
1/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.37%
1/269 • 7.5 months
|
0.74%
2/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.74%
2/269 • 7.5 months
|
1.1%
3/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/269 • 7.5 months
|
0.37%
1/269 • 7.5 months
|
0.00%
0/269 • 7.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs may not publish results from this generic (ANDA) study unless reviewed and approved by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER