The Use of Oracea and Epiduo Forte in Severe Acne Patients

NCT03457636 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ORA-1801
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• IGA Score

  12 weeks

• Inflammatory Lesion Count

  Baseline, Week 4, Week 8, Week 12

• Non-inflammatory Lesion Count

  Baseline, Week 4, Week 8, Week 12

Study Arms (1)

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

Drug: Doxycycline Anhydrous 40 MG; Drug: Adapalene/Benzoyl Peroxide Gel 0.3-2.5%

Interventions

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

Also known as: Oracea

doxycycline anhydrous and adapalene/benzoyl peroxide

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

Also known as: Epiduo Forte 0.3%-2.5% Topical Gel

doxycycline anhydrous and adapalene/benzoyl peroxide

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Derm Research, PLLC: lead

Study Sites (1)

Skin Sciences, PLLC

Louisville, Kentucky, 40014, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Doxycycline; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Naphthalenes; Benzoyl Peroxide; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: M. McAllister
• Organization: Skin Sciences, PLLC

mmdermresearch@yahoo.com

5024519000

Study Officials

• Leon H. Kircik, M.D.

  Skin Sciences, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 7, 2018
• Study Start: March 19, 2018
• Primary Completion: November 1, 2018
• Study Completion: January 4, 2019
• Last Updated: April 3, 2019
• Results First Posted: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)