Trial Outcomes & Findings for A Treatment for Severe Inflammatory Acne Subjects (NCT NCT02899000)

NCT ID: NCT02899000

Last Updated: 2022-12-09

Results Overview

Change in Number of Inflammatory Lesions from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 186 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2022-12-09

Participant Flow

Participant milestones

Measure	Acne Treatment Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Overall Study STARTED	186
Overall Study COMPLETED	157
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Treatment for Severe Inflammatory Acne Subjects

Baseline characteristics by cohort

Measure	Acne Treatment n=175 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Age, Continuous	19.6 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants
Race (NIH/OMB) White	139 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	175 participants n=5 Participants
IGA 4 (Investigator's Global Assessment Score)	175 Participants n=5 Participants
Total Lesion Count	108.1 Lesion Count STANDARD_DEVIATION 48.43 • n=5 Participants
Inflammatory Lesion Count	44.1 Lesion Count STANDARD_DEVIATION 21.29 • n=5 Participants
Non-inflammatory Lesion Count	63.9 Lesion Count STANDARD_DEVIATION 38.9 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient.

Change in Number of Inflammatory Lesions from baseline.

Outcome measures

Measure

Acne Treatment n=185 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)

Change in Number of Inflammatory Lesions

-30.1 Inflammatory lesions Standard Deviation 22.3

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population.

IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1)

Outcome measures

Measure	Acne Treatment n=186 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Number and Percent of Subjects With IGA Success Week 4	9 Participants
Number and Percent of Subjects With IGA Success Week 8	44 Participants
Number and Percent of Subjects With IGA Success Week 12	69 Participants

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient.

Percent Change From Baseline in Total Lesion Count.

Outcome measures

Measure	Acne Treatment n=185 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Percent Change From Baseline in Total Lesion Count Week 4	-38.9 percent change in lesions Standard Deviation 28.5
Percent Change From Baseline in Total Lesion Count Week 8	-53.9 percent change in lesions Standard Deviation 30.3
Percent Change From Baseline in Total Lesion Count Week 12	-62.6 percent change in lesions Standard Deviation 31.9

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient.

Change From Baseline in Total Lesion Count.

Outcome measures

Measure	Acne Treatment n=185 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Change From Baseline in Total Lesion Count Week 4	-43.7 change in lesions Standard Deviation 39.4
Change From Baseline in Total Lesion Count Week 8	-59.4 change in lesions Standard Deviation 46.5
Change From Baseline in Total Lesion Count Week 12	-69.2 change in lesions Standard Deviation 49.6

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient.

Percent Change From Baseline in Inflammatory Lesion Count.

Outcome measures

Measure	Acne Treatment n=185 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Percent Change From Baseline in Inflammatory Lesion Count Week 4	-38.5 percent change in lesions Standard Deviation 37.9
Percent Change From Baseline in Inflammatory Lesion Count Week 8	-55.0 percent change in lesions Standard Deviation 31.9
Percent Change From Baseline in Inflammatory Lesion Count Week 12	-66.2 percent change in lesions Standard Deviation 30.5

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient.

Change From Baseline in Inflammatory Lesion Count.

Outcome measures

Measure	Acne Treatment n=185 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Change From Baseline in Inflammatory Lesion Count Week 4	-18.9 change in lesions Standard Deviation 19.6
Change From Baseline in Inflammatory Lesion Count Week 8	-25.9 change in lesions Standard Deviation 22.2
Change From Baseline in Inflammatory Lesion Count Week 12	-30.1 change in lesions Standard Deviation 22.3

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient.

Percent Change From Baseline in Non-Inflammatory Lesion Count.

Outcome measures

Measure	Acne Treatment n=185 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Percent Change From Baseline in Non-Inflammatory Lesion Count Week 4	-34.6 percent change in lesions Standard Deviation 45.6
Percent Change From Baseline in Non-Inflammatory Lesion Count Week 8	-50.2 percent change in lesions Standard Deviation 36.9
Percent Change From Baseline in Non-Inflammatory Lesion Count Week 12	-58.7 percent change in lesions Standard Deviation 38.8

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient.

Change From Baseline in Non-Inflammatory Lesion Count.

Outcome measures

Measure	Acne Treatment n=185 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Change From Baseline in Non-Inflammatory Lesion Count Week 4	-24.9 change in lesions Standard Deviation 28.4
Change From Baseline in Non-Inflammatory Lesion Count Week 8	-33.6 change in lesions Standard Deviation 33.0
Change From Baseline in Non-Inflammatory Lesion Count Week 12	-39.1 change in lesions Standard Deviation 36.2

SECONDARY outcome

Timeframe: Weeks 0, 4, 8, and 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population.

At each visit, subjects were evaluated by the investigator to determine whether (in the opinion of the investigator) they would consider them as candidates for oral isotretinoin therapy.

The outcome measure reports the number and % of subjects who, in the opinion of the investigator, were not considered to be "a candidate for oral isotretinoin therapy."

Outcome measures

Measure	Acne Treatment n=186 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates Week 0	0 Participants
Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates Week 4	78 Participants
Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates Week 8	121 Participants
Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates Week 12	149 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population.

Subject Assessment of Acne Improvement on a 6 point scale (0 = Complete Improvement, 1 = Marked Improvement, 2 = Moderate Improvement, 3 = Minimal Improvement, 4 = No Change, 5 = Worse).

Outcome measures

Measure

Acne Treatment n=186 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)

Subject Assessment of Acne Improvement

1.3 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Week 12

Population: The Safety Population consisted of the ITT Population following exclusion of subjects who never took the treatment with certainty, based on drug accountability data. All safety analyses were summarized for the Safety Population.

Number and percent of subjects with any Treatment-Related Adverse Event

Outcome measures

Measure

Acne Treatment n=175 Participants Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)

Number and Percent of Adverse Events

27 Participants

Adverse Events

Acne Treatment

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acne Treatment n=175 participants at risk Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)
Gastrointestinal disorders Nausea	2.3% 4/175 • 12 Weeks Throughout the course of the study, all AEs were monitored and recorded along with date of onset, severity, relationship to study treatment, and outcome.
Nervous system disorders Headache	4.0% 7/175 • 12 Weeks Throughout the course of the study, all AEs were monitored and recorded along with date of onset, severity, relationship to study treatment, and outcome.
Skin and subcutaneous tissue disorders Erythema	2.9% 5/175 • 12 Weeks Throughout the course of the study, all AEs were monitored and recorded along with date of onset, severity, relationship to study treatment, and outcome.
Skin and subcutaneous tissue disorders Skin burning sensation	3.4% 6/175 • 12 Weeks Throughout the course of the study, all AEs were monitored and recorded along with date of onset, severity, relationship to study treatment, and outcome.

Additional Information

Dr. Jean Philippe York, Medical Affairs Manager

Galderma Laboratories, LP

Phone: 1-817-961-5468

Email: jp.york@galderma.com

Results disclosure agreements

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