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

This study has been completed.
Information provided by (Responsible Party):
Derm Research, PLLC Identifier:
First received: June 21, 2013
Last updated: February 26, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Acne Vulgaris
Drug: Doxycycline 100mg
Drug: Aczone 5% gel
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel Treatment

Resource links provided by NLM:

Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:
  • Percentage of Participants Who Remained Responders at Week 24 [ Time Frame: Assessed every 4 weeks, reported 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

Secondary Outcome Measures:
  • Inflammatory and Non-inflammatory Lesion Counts [ Time Frame: Every 4 weeks ]
  • Percentage of Participants Who Are Responders at Week 16 and 20 [ Time Frame: Assessed every 4 weeks, reported at weeks 16 and 20 ]
    Responders is the percentage of participants who have an IGA <3 at Week 16 and 20

  • Nodule Counts [ Time Frame: every four weeks ]
    number of nodules counted

  • Erythema [ Time Frame: every 4 weeks ]
    the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema

  • Dryness [ Time Frame: every 4 weeks ]
    the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness

  • Peeling [ Time Frame: every four weeks ]
    the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling

  • Oiliness [ Time Frame: every 4 weeks ]
    the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness

  • Pruritis [ Time Frame: every 4 weeks ]
    the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis

  • Burning [ Time Frame: every 4 weeks ]
    the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning

Enrollment: 32
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Vibramycin, Oracea, Adoxa, Atridox
Drug: Aczone 5% gel
Aczone 5% gel twice daily
Other Name: Dapsone

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.

Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01885910

United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
Principal Investigator: Leon H Kircik, MD DermResearch, PLLC
  More Information

Responsible Party: Derm Research, PLLC Identifier: NCT01885910     History of Changes
Other Study ID Numbers: IIT-000508
Study First Received: June 21, 2013
Results First Received: October 7, 2014
Last Updated: February 26, 2015

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents processed this record on May 22, 2017