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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Drug: Doxycycline Anhydrous 40 MG Drug: Adapalene/Benzoyl Peroxide Gel 0.3-2.5% Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Oracea and Epiduo Forte in Severe Acne Patients
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : January 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: 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
Drug: 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
Other Name: Oracea

Drug: 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
Other Name: Epiduo Forte 0.3%-2.5% Topical Gel




Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) Score [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
    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.


Secondary Outcome Measures :
  1. IGA Score [ Time Frame: 12 weeks ]
    The percent of subjects who have at least a 2 grade improvement on IGA score

  2. Inflammatory Lesion Count [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
    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.

  3. Non-inflammatory Lesion Count [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
    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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • postmenopausal for at least 12 months prior to study drug administration;
  • without a uterus and/or both ovaries; or
  • has been surgically sterile for at least 6 months prior to study drug administration

Reliable methods of contraception are:

  • hormonal methods or intrauterine device in use ≥90 days prior to study drug administration;
  • barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
  • vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice) [Exception: female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.] ii. Facial acne IGA score of 4 iii. Minimum of 20 or more inflammatory lesions and 20 or more non-inflammatory lesions and not more than 4 nodules iv. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian

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 -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457636


Locations
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United States, Kentucky
Skin Sciences, PLLC
Louisville, Kentucky, United States, 40014
Sponsors and Collaborators
Derm Research, PLLC
Investigators
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Principal Investigator: Leon H. Kircik, M.D. Skin Sciences, PLLC
  Study Documents (Full-Text)

Documents provided by Derm Research, PLLC:

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Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT03457636     History of Changes
Other Study ID Numbers: ORA-1801
First Posted: March 7, 2018    Key Record Dates
Results First Posted: March 20, 2019
Last Update Posted: April 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Doxycycline
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents