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The Use of Oracea and Epiduo Forte in Severe Acne Patients

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ClinicalTrials.gov Identifier: NCT03457636
Recruitment Status : Completed
First Posted : March 7, 2018
Results First Posted : March 20, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Derm Research, PLLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: Doxycycline Anhydrous 40 MG
Drug: Adapalene/Benzoyl Peroxide Gel 0.3-2.5%
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxycycline Anhydrous 40 mg Once Daily and Adapalene/Benzoyl p
Hide Arm/Group Description

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

Period Title: Overall Study
Started 22
Completed 20
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Hide Arm/Group Description

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

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
19  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  25.0%
White
15
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Investigator Global Assessment (IGA) Score
Hide Description 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.
Time Frame Baseline, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Almost Clear
0
   0.0%
Clear
0
   0.0%
Severe
20
 100.0%
Moderate
0
   0.0%
Mild
0
   0.0%
Week 4 Almost Clear
0
   0.0%
Clear
0
   0.0%
Severe
5
  25.0%
Moderate
15
  75.0%
Mild
0
   0.0%
Week 8 Almost Clear
2
  10.0%
Clear
0
   0.0%
Severe
0
   0.0%
Moderate
10
  50.0%
Mild
8
  40.0%
Week 12 Almost Clear
6
  30.0%
Clear
0
   0.0%
Severe
0
   0.0%
Moderate
1
   5.0%
Mild
13
  65.0%
2.Secondary Outcome
Title IGA Score
Hide Description The percent of subjects who have at least a 2 grade improvement on IGA score
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
19
  95.0%
3.Secondary Outcome
Title Inflammatory Lesion Count
Hide Description Inflammatory 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.
Time Frame Baseline, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Median (Standard Deviation)
Unit of Measure: count of lesions
Baseline 33  (7)
Week 4 21  (6)
Week 8 12  (5)
Week 12 6  (4)
4.Secondary Outcome
Title Non-inflammatory Lesion Count
Hide Description Non-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.
Time Frame Baseline, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Median (Standard Deviation)
Unit of Measure: lesion count
Baseline 33  (7)
Week 4 27  (7)
Week 8 17  (7)
Week 12 9  (6)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Hide Arm/Group Description

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

All-Cause Mortality
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide
Affected / at Risk (%) # Events
Total   6/20 (30.00%)    
Gastrointestinal disorders   
nausea   1/20 (5.00%)  1
Infections and infestations   
sinus infection   1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
fracture right foot   1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
generalized sunburn   1/20 (5.00%)  1
rash between and under breasts   1/20 (5.00%)  1
sunburn on face   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: M. McAllister
Organization: Skin Sciences, PLLC
Phone: 5024519000
Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT03457636     History of Changes
Other Study ID Numbers: ORA-1801
First Submitted: February 27, 2018
First Posted: March 7, 2018
Results First Submitted: February 28, 2019
Results First Posted: March 20, 2019
Last Update Posted: April 3, 2019