AcnePhase 4NCT02944461

Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

A Phase 4 study testing Dapsone 7.5 % gel in people with Acne, run by Derm Research, PLLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Acne
What is being tested?: Dapsone 7.5 % gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 3 sitesUnited States
Study dates: Oct 2016to 11 Sep 2017
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 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Male and female subjects of any race and at least 12 years of age.
Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
Truncal acne IGA score of 3.
Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Who cannot join

Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
Subjects who have an allergy or sensitivity to any component of the test medication.
Subjects who have not complied with the proper wash out periods for prohibited medications.
Evidence of recent drug or alcohol abuse.
Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
Exposure to an investigational drug within 30 days of the Baseline visit.
Medical condition that contraindicates the subject's participation in the study.
History of poor cooperation, non-compliance with medical treatment or unreliability.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

James Q. DelRosso DO, LLC
Las Vegas, Nevada, 89117
DermResearch, PLLC
Louisville, Kentucky, 40014
Dermatology and Laser Surgery
Sacramento, California, 95819

Other trials in United States

About this study

To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Read the detailed description

This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Conditions: Acne
Being tested: Dapsone 7.5 % 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.

Dapsone 7.5 % gelDrug
Also called Aczone
Dapsone gel 7.5% applied once daily to truncal acne

Study groups in NCT02944461
Study group	Role	What they receive
Dapsone gel 7.5%	Experimental	Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Receives: Drug: Dapsone 7.5 % gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale
Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe
Measured: 16 weeks

Secondary outcomes (3)

The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
Measured: 16 Weeks
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
Measured: 16 Weeks
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline
Measured: 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201611 Sep 2017

First posted25 Oct 2016 (estimated)
Study startOct 2016
Primary completionSep 2017
Study completion11 Sep 2017

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 AcneStudies 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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02944461
Sponsor's protocol ID: ACZ1601
Status last verified: Mar 2019
First submitted: 4 Oct 2016
Last updated: 3 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
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All Acne trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
ClinicalTrials.gov ID: NCT02944461
Acronym / sponsor ID: ACZ1601
Conditions: Acne
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Derm Research, PLLCUniversity, hospital or other
Study start: Oct 2016
Primary completion: Sep 2017 (actual)
Study completion: 11 Sep 2017 (actual)
First posted: 25 Oct 2016 (estimated)
Results: Posted 1 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Detailed description

This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dapsone gel 7.5%	Experimental	Drug: Dapsone 7.5 % gelDapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Male and female subjects of any race and at least 12 years of age.
Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
Truncal acne IGA score of 3.
Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Key exclusion criteria (8 listed)

Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
Subjects who have an allergy or sensitivity to any component of the test medication.
Subjects who have not complied with the proper wash out periods for prohibited medications.
Evidence of recent drug or alcohol abuse.
Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.

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
Dapsone 7.5 % gelAlso: AczoneDapsone gel 7.5% applied once daily to truncal acne	Drug	Dapsone gel 7.5%

Primary outcome

Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale
Time frame: 16 weeks
Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe

3 secondary outcomes

The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
Time frame: 16 Weeks
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
Time frame: 16 Weeks
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline
Time frame: 16 Weeks

Results and safety

Results posted to the registry on 1 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapsone Gel 7.5%	20	15

Primary outcome: Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	Dapsone Gel 7.5% n = 15
week 4	0
week 10	3
week 16	7

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapsone Gel 7.5%	0 of 20 (0%)	3 of 20 (15%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acne

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
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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, M.D. study director

DermResearch PLLC

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapsone 7.5 % gel in people with Acne, run by Derm Research, PLLC at 3 sites 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 8 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 1 Mar 2019). 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?

Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02944461.

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 3 Apr 2019.