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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885910
• Other study ID #: IIT-000508
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2013
• Last updated: February 26, 2015
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Derm Research, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Doxycycline 100mg
Doxycycline 100mg by mouth once daily
• Aczone 5% gel
Aczone 5% gel twice daily

Locations

Country	Name	City	State
United States	DermResearch, PLLC	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Derm Research, PLLC	WFH MEDICAL, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Inflammatory and Non-inflammatory Lesion Counts		Every 4 weeks	No
Secondary	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	Assessed every 4 weeks, reported at weeks 16 and 20	No
Secondary	Nodule Counts	number of nodules counted	every four weeks	No
Secondary	Erythema	the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema	every 4 weeks	No
Secondary	Dryness	the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness	every 4 weeks	No
Secondary	Peeling	the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling	every four weeks	No
Secondary	Oiliness	the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness	every 4 weeks	No
Secondary	Pruritis	the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis	every 4 weeks	No
Secondary	Burning	the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning	every 4 weeks	No