Acne Vulgaris
Conditions
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.
Interventions
DRUGDoxycycline 100mg
Doxycycline 100mg by mouth once daily
DRUGAczone 5% gel
Aczone 5% gel twice daily
Sponsors
WFH MEDICAL, LLC
Derm Research, PLLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Nodule Counts | every four weeks | number of nodules counted |
| Erythema | every 4 weeks | the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema |
| Dryness | every 4 weeks | the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness |
| Inflammatory and Non-inflammatory Lesion Counts | Every 4 weeks | — |
| Oiliness | every 4 weeks | the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness |
| 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 |
| Burning | every 4 weeks | the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning |
| Peeling | every four weeks | the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling |
Countries
United States
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Aczone/Doxy 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 | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Aczone/Doxy |
|---|---|
| Age, Categorical <=18 years | 13 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 24.8 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aczone/Doxy | Percentage of Participants Who Remained Responders at Week 24 | 82 percentage of particpants |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Burning
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
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Burning | baseline | 0.1 units on a scale | Standard Deviation 0.5 |
| Aczone/Doxy | Burning | week 16 (N=23) | 0.1 units on a scale | Standard Deviation 0.4 |
| Aczone/Doxy | Burning | week 20 (N=23) | 0 units on a scale | Standard Deviation 0 |
| Aczone/Doxy | Burning | week 24 (N=22) | 0 units on a scale | Standard Deviation 0.2 |
Secondary
Dryness
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
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Dryness | baseline | 0.6 units on a scale | Standard Deviation 0.8 |
| Aczone/Doxy | Dryness | week 16 (N=23) | 0.3 units on a scale | Standard Deviation 0.6 |
| Aczone/Doxy | Dryness | week 20 (N=23) | 0.1 units on a scale | Standard Deviation 0.3 |
| Aczone/Doxy | Dryness | week 24 (N=22) | 0.1 units on a scale | Standard Deviation 0.3 |
Secondary
Erythema
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
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Erythema | Baseline | 1.3 units on a scale | Standard Deviation 0.8 |
| Aczone/Doxy | Erythema | week 16 (N=23) | 0.7 units on a scale | Standard Deviation 0.9 |
| Aczone/Doxy | Erythema | week 20 (N=23) | 0.9 units on a scale | Standard Deviation 0.8 |
| Aczone/Doxy | Erythema | week 24 (N=22) | 1.1 units on a scale | Standard Deviation 0.9 |
Secondary
Inflammatory and Non-inflammatory Lesion Counts
Time frame: Every 4 weeks
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Inflammatory and Non-inflammatory Lesion Counts | week 20 (n=23,23) | 7.3 lesions | Standard Deviation 9.2 |
| Aczone/Doxy | Inflammatory and Non-inflammatory Lesion Counts | week 16 (n=23,23) | 5.8 lesions | Standard Deviation 4.9 |
| Aczone/Doxy | Inflammatory and Non-inflammatory Lesion Counts | week 24 (n=22,22) | 7.0 lesions | Standard Deviation 9.1 |
| Aczone/Doxy | Inflammatory and Non-inflammatory Lesion Counts | baseline | 27.3 lesions | Standard Deviation 14.6 |
| Aczone/Doxy - Non Inflammatory | Inflammatory and Non-inflammatory Lesion Counts | week 24 (n=22,22) | 6.6 lesions | Standard Deviation 10.3 |
| Aczone/Doxy - Non Inflammatory | Inflammatory and Non-inflammatory Lesion Counts | week 16 (n=23,23) | 10.0 lesions | Standard Deviation 13.9 |
| Aczone/Doxy - Non Inflammatory | Inflammatory and Non-inflammatory Lesion Counts | week 20 (n=23,23) | 8.3 lesions | Standard Deviation 11.6 |
| Aczone/Doxy - Non Inflammatory | Inflammatory and Non-inflammatory Lesion Counts | baseline | 38.3 lesions | Standard Deviation 20.8 |
Secondary
Nodule Counts
number of nodules counted
Time frame: every four weeks
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Nodule Counts | Baseline | 0.4 nodules | Standard Deviation 0.7 |
| Aczone/Doxy | Nodule Counts | Week 16 (N=23) | 0.1 nodules | Standard Deviation 0.4 |
| Aczone/Doxy | Nodule Counts | Week 20 (N=23) | 0.1 nodules | Standard Deviation 0.5 |
| Aczone/Doxy | Nodule Counts | Week 24 (N=22) | 0.3 nodules | Standard Deviation 0.9 |
Secondary
Oiliness
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
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Oiliness | baseline | 1.6 units on a scale | Standard Deviation 1.1 |
| Aczone/Doxy | Oiliness | week 16 (N=23) | 0.8 units on a scale | Standard Deviation 0.8 |
| Aczone/Doxy | Oiliness | week 20 (N=23) | 0.6 units on a scale | Standard Deviation 0.7 |
| Aczone/Doxy | Oiliness | week 24 (N=22) | 0.3 units on a scale | Standard Deviation 0.5 |
Secondary
Peeling
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
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Peeling | baseline | 0.4 units on a scale | Standard Deviation 0.9 |
| Aczone/Doxy | Peeling | week 16 (N=23) | 0.1 units on a scale | Standard Deviation 0.3 |
| Aczone/Doxy | Peeling | week 20 (N=23) | 0.1 units on a scale | Standard Deviation 0.3 |
| Aczone/Doxy | Peeling | week 24 (N=22) | 0.1 units on a scale | Standard Deviation 0.3 |
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
Time frame: Assessed every 4 weeks, reported at weeks 16 and 20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aczone/Doxy | Percentage of Participants Who Are Responders at Week 16 and 20 | responders at week 16 | 78 percentage of participants |
| Aczone/Doxy | Percentage of Participants Who Are Responders at Week 16 and 20 | responders at week 20 | 87 percentage of participants |
Secondary
Pruritis
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
Population: participants with data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aczone/Doxy | Pruritis | baseline | 0.4 units on a scale | Standard Deviation 0.8 |
| Aczone/Doxy | Pruritis | week 16 (N=23) | 0.2 units on a scale | Standard Deviation 0.6 |
| Aczone/Doxy | Pruritis | week 20 (N=23) | 0.1 units on a scale | Standard Deviation 0.3 |
| Aczone/Doxy | Pruritis | week 24 (N=22) | 0 units on a scale | Standard Deviation 0.2 |