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This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and weeks 4, 8, and 12. All subjects will receive Oracea once daily (QD) and Epiduo Forte at Baseline. We will evaluate Investigator Global Assessment (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, adverse events and concomitant medications.
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and weeks 4,8, and 12. All subjects will receive Oracea once daily (QD) and Epiduo Forte at Baseline. WE will evaluate Investigator Global Assessment (IGA), total lesion count, adverse events and concomitant medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxycycline anhydrous and adapalene/benzoyl peroxide | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline Anhydrous 40 MG | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Score | 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. | Baseline, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| IGA Score | The percent of subjects who have at least a 2 grade improvement on IGA score | 12 weeks |
| Inflammatory Lesion Count | 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. |
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Inclusion Criteria:
i. Outpatient, male or female subjects of any race, and at least 12 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25 milli-international units/milliliter [mIU/ml] for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:
A female is considered of childbearing potential unless she is:
Reliable methods of contraception are:
Exclusion Criteria:
i. Female subjects who are pregnant (positive urine pregnancy test ), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control ii. Allergy or sensitivity to any component of the test medication iii. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I)> iv. Medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the clinical study v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse vii. History of poor cooperation, non-compliance with medical treatment, or unreliability viii. Exposure to an investigational drug study within 30 days of the Baseline Visit -
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| Name | Affiliation | Role |
|---|---|---|
| Leon H. Kircik, M.D. | Skin Sciences, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Sciences, PLLC | Louisville | Kentucky | 40014 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator Global Assessment (IGA) Score | 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. | Posted | Count of Participants | Participants | Baseline, Week 4, Week 8, Week 12 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| generalized sunburn | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. McAllister | Skin Sciences, PLLC | 5024519000 | mmdermresearch@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2018 | Feb 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D000068816 | Adapalene |
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Adapalene/Benzoyl Peroxide Gel 0.3-2.5% | Drug | 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 |
|
|
| Baseline, Week 4, Week 8, Week 12 |
| Non-inflammatory Lesion Count | 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. | Baseline, Week 4, Week 8, Week 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | IGA Score | The percent of subjects who have at least a 2 grade improvement on IGA score | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Inflammatory Lesion Count | 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. | Posted | Median | Standard Deviation | count of lesions | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| Secondary | Non-inflammatory Lesion Count | 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. | Posted | Median | Standard Deviation | lesion count | Baseline, Week 4, Week 8, Week 12 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 6 |
| 20 |
| fracture right foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| sinus infection | Infections and infestations | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| rash between and under breasts | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| sunburn on face | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009281 | Naphthalenes |
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
|
| Mild |
|
|
| Mild |
|
|
| Mild |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|