Acne VulgarisPhase 4NCT01885910
Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
A Phase 4 study testing Doxycycline 100mg and Aczone 5% gel in people with Acne Vulgaris, run by Derm Research, PLLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Doxycycline 100mg and Aczone 5% gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel Treatment
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Doxycycline 100mg, Aczone 5% gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline 100mgDrug
Also called Vibramycin, Oracea, Adoxa, Atridox
Doxycycline 100mg by mouth once daily
Aczone 5% gelDrug
Also called Dapsone
Aczone 5% gel twice daily
| Study group | Role | What they receive |
|---|---|---|
| doxy + aczone | Experimental | 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 Receives: Drug: Doxycycline 100mg; Drug: Aczone 5% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed every 4 weeks, reported at Week 24
Secondary outcomes (9)
Inflammatory and Non-inflammatory Lesion Counts
Measured: Every 4 weeks
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
Measured: Assessed every 4 weeks, reported at weeks 16 and 20
Nodule Counts
number of nodules counted
Measured: every four weeks
Erythema
the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema
Measured: every 4 weeks
Dryness
the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness
Measured: every 4 weeks
Peeling
the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling
Measured: every four weeks
Oiliness
the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness
Measured: every 4 weeks
Pruritis
the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis
Measured: every 4 weeks
Burning
the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derm Research, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- WFH MEDICAL, LLC
- Responsible party
- Sponsor
- Investigators
- Leon H Kircik, MD, Principal investigator, DermResearch, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885910
- Sponsor's protocol ID
- IIT-000508
- Status last verified
- Feb 2015
- First submitted
- 21 Jun 2013
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel Treatment
- ClinicalTrials.gov ID
- NCT01885910
- Acronym / sponsor ID
- IIT-000508
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Derm Research, PLLCUniversity, hospital or other
- Collaborators
- WFH MEDICAL, LLC
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doxy + aczone | Experimental | Drug: Doxycycline 100mg, Drug: Aczone 5% gelSubjects 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 |
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline 100mgAlso: Vibramycin, Oracea, Adoxa, AtridoxDoxycycline 100mg by mouth once daily | Drug | doxy + aczone |
| Aczone 5% gelAlso: DapsoneAczone 5% gel twice daily | Drug | doxy + aczone |
Primary outcome
Percentage of Participants Who Remained Responders at Week 24
Time frame: 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
9 secondary outcomes
Inflammatory and Non-inflammatory Lesion Counts
Time frame: Every 4 weeks
Percentage of Participants Who Are Responders at Week 16 and 20
Time frame: Assessed every 4 weeks, reported at weeks 16 and 20
Nodule Counts
Time frame: every four weeks
Erythema
Time frame: every 4 weeks
Dryness
Time frame: every 4 weeks
Peeling
Time frame: every four weeks
Oiliness
Time frame: every 4 weeks
Pruritis
Time frame: every 4 weeks
Burning
Time frame: every 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon H Kircik, MD principal investigator
DermResearch, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline 100mg and Aczone 5% gel in people with Acne Vulgaris, run by Derm Research, PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Remained Responders at Week 24 (time frame: Assessed every 4 weeks, reported at Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.