Trial Outcomes & Findings for Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel (NCT NCT01885910)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

Assessed every 4 weeks, reported at Week 24

Results posted on

2015-02-27

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Doxy + Aczone 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.
Overall Study STARTED	32
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aczone/Doxy n=32 Participants 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
Age, Continuous	24.8 years STANDARD_DEVIATION 10.9 • n=5 Participants
Age, Categorical <=18 years	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 4 weeks, reported at Week 24

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

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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=22 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Percentage of Participants Who Remained Responders at Week 24	82 percentage of particpants	—

SECONDARY outcome

Timeframe: Every 4 weeks

Population: participants with data

Outcome measures

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

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=23 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Percentage of Participants Who Are Responders at Week 16 and 20 responders at week 16	78 percentage of participants	—
Percentage of Participants Who Are Responders at Week 16 and 20 responders at week 20	87 percentage of participants	—

SECONDARY outcome

Timeframe: every four weeks

Population: participants with data

number of nodules counted

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=31 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Nodule Counts Baseline	0.4 nodules Standard Deviation 0.7	—
Nodule Counts Week 16 (N=23)	0.1 nodules Standard Deviation 0.4	—
Nodule Counts Week 20 (N=23)	0.1 nodules Standard Deviation 0.5	—
Nodule Counts Week 24 (N=22)	0.3 nodules Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: every 4 weeks

Population: participants with data

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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=31 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Erythema Baseline	1.3 units on a scale Standard Deviation 0.8	—
Erythema week 16 (N=23)	0.7 units on a scale Standard Deviation 0.9	—
Erythema week 20 (N=23)	0.9 units on a scale Standard Deviation 0.8	—
Erythema week 24 (N=22)	1.1 units on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: every 4 weeks

Population: participants with data

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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=31 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Dryness baseline	0.6 units on a scale Standard Deviation 0.8	—
Dryness week 16 (N=23)	0.3 units on a scale Standard Deviation 0.6	—
Dryness week 20 (N=23)	0.1 units on a scale Standard Deviation 0.3	—
Dryness week 24 (N=22)	0.1 units on a scale Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: every four weeks

Population: participants with data

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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=31 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Peeling baseline	0.4 units on a scale Standard Deviation 0.9	—
Peeling week 16 (N=23)	0.1 units on a scale Standard Deviation 0.3	—
Peeling week 20 (N=23)	0.1 units on a scale Standard Deviation 0.3	—
Peeling week 24 (N=22)	0.1 units on a scale Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: every 4 weeks

Population: participants with data

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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=31 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Oiliness baseline	1.6 units on a scale Standard Deviation 1.1	—
Oiliness week 16 (N=23)	0.8 units on a scale Standard Deviation 0.8	—
Oiliness week 20 (N=23)	0.6 units on a scale Standard Deviation 0.7	—
Oiliness week 24 (N=22)	0.3 units on a scale Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: every 4 weeks

Population: participants with data

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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=31 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Pruritis baseline	0.4 units on a scale Standard Deviation 0.8	—
Pruritis week 16 (N=23)	0.2 units on a scale Standard Deviation 0.6	—
Pruritis week 20 (N=23)	0.1 units on a scale Standard Deviation 0.3	—
Pruritis week 24 (N=22)	0 units on a scale Standard Deviation 0.2	—

SECONDARY outcome

Timeframe: every 4 weeks

Population: participants with data

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

Outcome measures

Outcome measures
Measure	Aczone/Doxy n=31 Participants 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	Aczone/Doxy - Non Inflammatory non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Burning week 20 (N=23)	0 units on a scale Standard Deviation 0	—
Burning baseline	0.1 units on a scale Standard Deviation 0.5	—
Burning week 16 (N=23)	0.1 units on a scale Standard Deviation 0.4	—
Burning week 24 (N=22)	0 units on a scale Standard Deviation 0.2	—

Adverse Events

Doxy + Aczone

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Doxy + Aczone n=32 participants at risk 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.
Gastrointestinal disorders nausea	9.4% 3/32 • Number of events 3 • 6 months 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.
Skin and subcutaneous tissue disorders burning	3.1% 1/32 • Number of events 1 • 6 months 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.
Gastrointestinal disorders vomiting	3.1% 1/32 • Number of events 1 • 6 months 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.
Vascular disorders headache	3.1% 1/32 • Number of events 1 • 6 months 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.
Skin and subcutaneous tissue disorders pruritis	3.1% 1/32 • Number of events 1 • 6 months 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.

Additional Information

Dr. Leon Kircik

DermResearch, PLLC

Phone: 502-451-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place