Trial Outcomes & Findings for A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV) (NCT NCT04451330)

Last Updated: 2022-05-10

Results Overview

Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

202 participants

Primary outcome timeframe

From Baseline to Week 12

Results posted on

2022-05-10

Participant Flow

Study was conducted at United States of America and Puerto Rico between 29 Jul 2020 and 26 Apr 2021.

A total of 202 participants were randomized in 2:1 ratio in 2 treatment groups.

Participant milestones

Participant milestones
Measure	Trifarotene (CD5789) Cream + Doxycycline Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Overall Study STARTED	133	69
Overall Study COMPLETED	123	65
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Trifarotene (CD5789) Cream + Doxycycline Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Overall Study Adverse Event	1	2
Overall Study Lost to Follow-up	5	0
Overall Study Withdrawal by Subject	3	1
Overall Study Withdrawal by parent/guardian	1	0
Overall Study Other than specified	0	1

Baseline Characteristics

A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trifarotene + Doxycycline n=133 Participants Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo n=69 Participants Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Total n=202 Participants Total of all reporting groups
Age, Continuous	20.0 years STANDARD_DEVIATION 7.30 • n=93 Participants	20.3 years STANDARD_DEVIATION 8.92 • n=4 Participants	20.1 years STANDARD_DEVIATION 7.87 • n=27 Participants
Sex: Female, Male Female	80 Participants n=93 Participants	43 Participants n=4 Participants	123 Participants n=27 Participants
Sex: Female, Male Male	53 Participants n=93 Participants	26 Participants n=4 Participants	79 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=93 Participants	20 Participants n=4 Participants	70 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=93 Participants	49 Participants n=4 Participants	132 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	6 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) White	114 Participants n=93 Participants	58 Participants n=4 Participants	172 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Facial Total Lesions Counts	101.5 Lesion counts STANDARD_DEVIATION 40.11 • n=93 Participants	100.7 Lesion counts STANDARD_DEVIATION 33.91 • n=4 Participants	101.2 Lesion counts STANDARD_DEVIATION 38.02 • n=27 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 12

Population: The ITT population included all participants who were randomized.

Outcome measures

Outcome measures
Measure	Trifarotene + Doxycycline n=133 Participants Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo n=69 Participants Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12	-69.1 Lesion counts Standard Deviation 2.28	-48.1 Lesion counts Standard Deviation 3.14

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: The ITT population included all participants who were randomized.

All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.

Outcome measures

Outcome measures
Measure	Trifarotene + Doxycycline n=133 Participants Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo n=69 Participants Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12	-29.4 Lesion counts Standard Error 1.09	-19.5 Lesion counts Standard Error 1.49

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: The ITT population included all participants who were randomized.

Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.

Outcome measures

Outcome measures
Measure	Trifarotene + Doxycycline n=133 Participants Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo n=69 Participants Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12	-39.5 Lesion counts Standard Deviation 1.42	-28.2 Lesion counts Standard Deviation 1.96

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: The ITT population included all participants who were randomized.

IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.

Outcome measures

Outcome measures
Measure	Trifarotene + Doxycycline n=133 Participants Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo n=69 Participants Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12	31.7 percentage of participants	15.8 percentage of participants

Adverse Events

Trifarotene + Doxycycline

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Trifarotene Vehicle + Doxycycline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trifarotene + Doxycycline n=133 participants at risk Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.	Trifarotene Vehicle + Doxycycline Placebo n=69 participants at risk Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Psychiatric disorders Self-Injurious Ideation	0.75% 1/133 • Number of events 1 • From Baseline up to Week 12. Analysis was performed on safety population which comprised of all randomized participants who applied/took the study drug at least once.	0.00% 0/69 • From Baseline up to Week 12. Analysis was performed on safety population which comprised of all randomized participants who applied/took the study drug at least once.

Other adverse events

Adverse event data not reported

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

Restriction type: OTHER