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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01885910
First Posted: June 25, 2013
Last Update Posted: February 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
WFH MEDICAL, LLC
Information provided by (Responsible Party):
Derm Research, PLLC
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

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

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
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): NCT01885910


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

Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01885910     History of Changes
Other Study ID Numbers: IIT-000508
First Submitted: June 21, 2013
First Posted: June 25, 2013
Results First Submitted: October 7, 2014
Results First Posted: February 26, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Dapsone
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents