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

• Sponsor: Derm Research, PLLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT01885910
• Collaborator: WFH MEDICAL, LLC (Other)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Doxycycline 100mg; Drug: Aczone 5% gel	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• 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
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Vibramycin, Oracea, Adoxa, Atridox ; Drug: Aczone 5% gel; Aczone 5% gel twice daily; Other Names: Dapsone

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Remained Responders at Week 24 [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

1. Inflammatory and Non-inflammatory Lesion Counts [Every 4 weeks]

2. Percentage of Participants Who Are Responders at Week 16 and 20 [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

3. Nodule Counts [every four weeks]

   number of nodules counted

4. Erythema [every 4 weeks]

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

5. Dryness [every 4 weeks]

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

6. Peeling [every four weeks]

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

7. Oiliness [every 4 weeks]

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

8. Pruritis [every 4 weeks]

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

9. Burning [every 4 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Derm Research, PLLC
• ClinicalTrials.gov Identifier: NCT01885910
• Other Study ID Numbers: IIT-000508
• First Posted: Jun 25, 2013
• Last Update Posted: Feb 27, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Acne Vulgaris; Doxycycline; Dapsone

Study Results

Participant Flow

Recruitment Details	Recruitment at 2 sites for subjects at least 12 years of age with moderate to severe acne vulgaris began June 2013 and ended December 2013
Pre-assignment Detail	Any subject might be excluded who is not at least 12 years of age, who does not have moderate to severe acne vulgaris based upon IGA score and lesion counts, who has not completed the proper washout of specified medications, or who has been in another investigational study 30 days prior

Arm/Group Title	Doxy + Aczone
Arm/Group Description	Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily 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.
Period Title: Overall Study
STARTED	32
COMPLETED	24
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Participants	32
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.8 (10.9)
Age (Count of Participants)
<=18 years	13 40.6%
Between 18 and 65 years	19 59.4%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	20 62.5%
Male	12 37.5%
Region of Enrollment (participants) [Number]
United States	32 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

only participants who were not lost to follow-up or did not withdraw consent were included in the final analysis

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	22
Number [percentage of particpants]	82

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aczone/Doxy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Inflammatory and Non-inflammatory Lesion Counts
Time Frame	Every 4 weeks

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy - Inflammatory	Aczone/Doxy - Non Inflammatory
Arm/Group Description	inflammatory lesion counts during treatment with aczone 5% and doxycycline 100mg	non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Measure Participants	31	31
baseline	27.3 (14.6)	38.3 (20.8)
week 16 (n=23,23)	5.8 (4.9)	10.0 (13.9)
week 20 (n=23,23)	7.3 (9.2)	8.3 (11.6)
week 24 (n=22,22)	7.0 (9.1)	6.6 (10.3)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	23
responders at week 16	78 243.8%
responders at week 20	87 271.9%

4. Secondary Outcome

Title	Nodule Counts
Description	number of nodules counted
Time Frame	every four weeks

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	31
Baseline	0.4 (0.7)
Week 16 (N=23)	0.1 (0.4)
Week 20 (N=23)	0.1 (0.5)
Week 24 (N=22)	0.3 (0.9)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	31
Baseline	1.3 (0.8)
week 16 (N=23)	0.7 (0.9)
week 20 (N=23)	0.9 (0.8)
week 24 (N=22)	1.1 (0.9)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	31
baseline	0.6 (0.8)
week 16 (N=23)	0.3 (0.6)
week 20 (N=23)	0.1 (0.3)
week 24 (N=22)	0.1 (0.3)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	31
baseline	0.4 (0.9)
week 16 (N=23)	0.1 (0.3)
week 20 (N=23)	0.1 (0.3)
week 24 (N=22)	0.1 (0.3)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	31
baseline	1.6 (1.1)
week 16 (N=23)	0.8 (0.8)
week 20 (N=23)	0.6 (0.7)
week 24 (N=22)	0.3 (0.5)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	31
baseline	0.4 (0.8)
week 16 (N=23)	0.2 (0.6)
week 20 (N=23)	0.1 (0.3)
week 24 (N=22)	0 (0.2)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

participants with data

Arm/Group Title	Aczone/Doxy
Arm/Group Description	subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Measure Participants	31
baseline	0.1 (0.5)
week 16 (N=23)	0.1 (0.4)
week 20 (N=23)	0 (0)
week 24 (N=22)	0 (0.2)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Subjects were interviewed regarding changes in their health and the severity of pruritis and burning at each study visit; each subject was graded at each study visit regarding their current severity of erythema, dryness, peeling and oiliness on a 5-point scale.
Arm/Group Title	Doxy + Aczone
Arm/Group Description	Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily 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.
All Cause Mortality
	Doxy + Aczone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Doxy + Aczone
	Affected / at Risk (%)	# Events
Total	0/32 (0%)
Other (Not Including Serious) Adverse Events
	Doxy + Aczone
	Affected / at Risk (%)	# Events
Total	7/32 (21.9%)
Gastrointestinal disorders
nausea	3/32 (9.4%)	3
vomiting	1/32 (3.1%)	1
Skin and subcutaneous tissue disorders
burning	1/32 (3.1%)	1
pruritis	1/32 (3.1%)	1
Vascular disorders
headache	1/32 (3.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.