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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
WFH MEDICAL, LLC
Information provided by (Responsible Party):
Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT01885910
First received: June 21, 2013
Last updated: May 16, 2014
Last verified: May 2014
  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 and Aczone 5% gel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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:
  • Investigator Global Assessment (IGA) of acne vulgaris [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory and non-inflammatory lesion counts [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Doxycycline 100mg and Aczone 5% gel
    Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks.
  Eligibility

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885910

Locations
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
WFH MEDICAL, LLC
  More Information

No publications provided

Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01885910     History of Changes
Other Study ID Numbers: IIT-000508
Study First Received: June 21, 2013
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014