Trial Outcomes & Findings for The Use of Oracea and Epiduo Forte in Severe Acne Patients (NCT NCT03457636)
NCT ID: NCT03457636
Last Updated: 2019-04-03
Results Overview
The IGA is an assessment by the Investigator to assess the severity of the subject's disease wherein 0=Clear Skin, 1=Almost Clear, 2=Mild Severity, 3=Moderate, 4=Severe, 5=Very Severe. Lower score indicate less severe disease.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Baseline, Week 4, Week 8, Week 12
Results posted on
2019-04-03
Participant Flow
Participant milestones
| Measure |
Doxycycline Anhydrous 40 mg Once Daily and Adapalene/Benzoyl p
All subjects will receive at Baseline doxycycline anhydrous 40 mg and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene-Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Doxycycline Anhydrous 40 mg Once Daily and Adapalene/Benzoyl p
All subjects will receive at Baseline doxycycline anhydrous 40 mg and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene-Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
The Use of Oracea and Epiduo Forte in Severe Acne Patients
Baseline characteristics by cohort
| Measure |
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
n=20 Participants
All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
|
Age, Continuous
|
19 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12The IGA is an assessment by the Investigator to assess the severity of the subject's disease wherein 0=Clear Skin, 1=Almost Clear, 2=Mild Severity, 3=Moderate, 4=Severe, 5=Very Severe. Lower score indicate less severe disease.
Outcome measures
| Measure |
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
n=20 Participants
All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
|
Investigator Global Assessment (IGA) Score
Baseline · Almost Clear
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Baseline · Clear
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Baseline · Severe
|
20 Participants
|
|
Investigator Global Assessment (IGA) Score
Baseline · Moderate
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Baseline · Mild
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 4 · Almost Clear
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 4 · Clear
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 4 · Severe
|
5 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 4 · Moderate
|
15 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 4 · Mild
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 8 · Almost Clear
|
2 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 8 · Clear
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 8 · Severe
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 8 · Moderate
|
10 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 8 · Mild
|
8 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 12 · Almost Clear
|
6 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 12 · Clear
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 12 · Severe
|
0 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 12 · Moderate
|
1 Participants
|
|
Investigator Global Assessment (IGA) Score
Week 12 · Mild
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe percent of subjects who have at least a 2 grade improvement on IGA score
Outcome measures
| Measure |
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
n=20 Participants
All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
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IGA Score
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Inflammatory lesions here include papules and pustules on the face from edge of hairline to mandibular line as counted by the Investigator. Lower counts indicate less severe disease.
Outcome measures
| Measure |
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
n=20 Participants
All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
|
Inflammatory Lesion Count
Baseline
|
33 count of lesions
Standard Deviation 7
|
|
Inflammatory Lesion Count
Week 4
|
21 count of lesions
Standard Deviation 6
|
|
Inflammatory Lesion Count
Week 8
|
12 count of lesions
Standard Deviation 5
|
|
Inflammatory Lesion Count
Week 12
|
6 count of lesions
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Non-inflammatory lesions here include open and closed comedones. These are counted on the face by the investigator from edge of hairline to mandibular line and lower count indicates less severe disease.
Outcome measures
| Measure |
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
n=20 Participants
All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
|
Non-inflammatory Lesion Count
Week 4
|
27 lesion count
Standard Deviation 7
|
|
Non-inflammatory Lesion Count
Baseline
|
33 lesion count
Standard Deviation 7
|
|
Non-inflammatory Lesion Count
Week 8
|
17 lesion count
Standard Deviation 7
|
|
Non-inflammatory Lesion Count
Week 12
|
9 lesion count
Standard Deviation 6
|
Adverse Events
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
n=20 participants at risk
All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks
Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
|
|---|---|
|
Skin and subcutaneous tissue disorders
generalized sunburn
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
fracture right foot
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Infections and infestations
sinus infection
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
nausea
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
rash between and under breasts
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
sunburn on face
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place