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

NCT01885910 | Completed Phase 4 Results

• 1 other identifier: IIT-000508
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Inflammatory and Non-inflammatory Lesion Counts

  Every 4 weeks

• Percentage of Participants Who Are Responders at Week 16 and 20

  Assessed every 4 weeks, reported at weeks 16 and 20

• Nodule Counts

  every four weeks

• Erythema

  every 4 weeks

• Dryness

  every 4 weeks

Study Arms (1)

doxy + aczone

EXPERIMENTAL

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; Drug: Aczone 5% gel

Interventions

Doxycycline 100mg DRUG

Doxycycline 100mg by mouth once daily

Also known as: Vibramycin, Oracea, Adoxa, Atridox

doxy + aczone

Aczone 5% gel DRUG

Aczone 5% gel twice daily

Also known as: Dapsone

doxy + aczone

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derm Research, PLLC: lead
• WFH MEDICAL, LLC: collaborator

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Doxycycline; Dapsone; Gels

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; Sulfones; Sulfur Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Leon Kircik
• Organization: DermResearch, PLLC

wedoderm@yahoo.com

502-451-9000

Study Officials

• Leon H Kircik, MD

  DermResearch, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: June 21, 2013
• First Posted: June 25, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 27, 2015
• Results First Posted: February 26, 2015

Record last verified: 2015-02

Locations

US (1)