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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Doxycycline 100mg

Aczone 5% gel

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

DermResearch, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

doxy + aczone

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inflammatory and Non-inflammatory Lesion Counts

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

Nodule Counts

number of nodules counted

Erythema

the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema

Dryness

the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness

Peeling

the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling

Oiliness

the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness

Pruritis

the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis

Burning

the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning

Full Information

NCT ID

NCT01885910

First Posted

June 21, 2013

Last Updated

February 26, 2015

Sponsor

Derm Research, PLLC

Collaborators

WFH MEDICAL, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01885910

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Derm Research, PLLC

Collaborators

WFH MEDICAL, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

doxy + aczone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Doxycycline 100mg

Other Intervention Name(s)

Vibramycin, Oracea, Adoxa, Atridox

Intervention Description

Doxycycline 100mg by mouth once daily

Intervention Type

Drug

Intervention Name(s)

Aczone 5% gel

Other Intervention Name(s)

Dapsone

Intervention Description

Aczone 5% gel twice daily

Primary Outcome Measure Information:

Title

Percentage of Participants Who Remained Responders at Week 24

Description

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

Time Frame

Assessed every 4 weeks, reported at Week 24

Secondary Outcome Measure Information:

Title

Inflammatory and Non-inflammatory Lesion Counts

Time Frame

Every 4 weeks

Title

Percentage of Participants Who Are Responders at Week 16 and 20

Description

Responders is the percentage of participants who have an IGA <3 at Week 16 and 20

Time Frame

Assessed every 4 weeks, reported at weeks 16 and 20

Title

Nodule Counts

Description

number of nodules counted

Time Frame

every four weeks

Title

Erythema

Description

the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema

Time Frame

every 4 weeks

Title

Dryness

Description

the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness

Time Frame

every 4 weeks

Title

Peeling

Description

the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling

Time Frame

every four weeks

Title

Oiliness

Description

the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness

Time Frame

every 4 weeks

Title

Pruritis

Description

the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis

Time Frame

every 4 weeks

Title

Burning

Description

the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning

Time Frame

every 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leon H Kircik, MD

Organizational Affiliation

DermResearch, PLLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

DermResearch, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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