Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel

Use of Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel Treatment

This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel following combination treatment with with doxycycline and Aczone 5% gel can maintain therapeutic response.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Doxycycline 100mg; Drug: Aczone 5% gel

Detailed Description

This is a two-center, open-label pilot study. The study is apprised of 7 study visits: Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and doxycycline 100mg by mouth once daily at Baseline. Those subjects achieving treatment response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID at Week 12. Subjects not achieving treatment response will discontinue study participation.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatient, male or female subjects of any race, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
• Facial acne vulgaris characterized by the following:

IGA Score >3 10-50 facial inflammatory lesions (papules,pustules) 10-100 facial non-inflammatory lesions (open/closed comedones)

• Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA Authorization forms

Exclusion Criteria:

• 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.
• Allergy/sensitivity to any component of the test treatment (Section 5.2), lincomycin, tetracyclines, or sulfites.
• Subjects who have not complied with the proper wash-out periods for prohibited medications/procedures (Supplement 1)>
• History of clinically significant anemia or hemolysis.
• History of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis).
• Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
• Evidence of recent alcohol or drug abuse
• Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
• History of poor cooperation, non-compliance with medical treatment or unreliability
• Participation in an investigational drug study within 30 days of the baseline visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: doxy + aczone; Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily and those who improve significantly are continued on Aczone gel alone to see if it can maintain therapeutic response	Drug: Doxycycline 100mg; Doxycycline 100mg by mouth once daily; Other Names: Vibramycin, Oracea, Adoxa, Atridox; Drug: Aczone 5% gel; Aczone 5% gel twice daily; Other Names: Dapsone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Remained Responders at Week 24	At week 12 responder had an IGA <3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained	Assessed every 4 weeks, reported at Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory and Non-inflammatory Lesion Counts		Every 4 weeks
Percentage of Participants Who Are Responders at Week 16 and 20	Responders is the percentage of participants who have an IGA <3 at Week 16 and 20	Assessed every 4 weeks, reported at weeks 16 and 20
Nodule Counts	number of nodules counted	every four weeks
Erythema	the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema	every 4 weeks
Dryness	the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness	every 4 weeks
Peeling	the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling	every four weeks
Oiliness	the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness	every 4 weeks
Pruritis	the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis	every 4 weeks
Burning	the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning	every 4 weeks

Collaborators and Investigators

• Sponsor: Derm Research, PLLC
• Collaborators: WFH MEDICAL, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (ESTIMATE): June 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 27, 2015
• Last Update Submitted That Met QC Criteria: February 26, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Doxycycline; Dapsone
• Other Study ID Numbers: IIT-000508