Acne VulgarisPhase 4NCT00243542
Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
A Phase 4 study testing ACZONE Gel, 5% in people with Acne Vulgaris, run by Allergan at 29 sites in United States.
Trial summary
The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders. ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ACZONE Gel, 5%
- How many people
- 64 participants
- Where
- 29 sitesUnited States
- Study dates
- Nov 2005to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible for this study, subjects must fulfill all of the following criteria:
- Male or female ≥12 years of age.
- A clear diagnosis of acne vulgaris, defined as ≥20 acne inflammatory and/or non-inflammatory lesions (≥10 of the acne lesions must be on the face, the others may be present on the neck, shoulders, upper chest, and upper back) at screening.
- A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal for the central reference laboratory.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- A dermal examination reveals the presence of severe cystic acne or acne conglobata.
- Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study.
- Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer.
- Subjects who are using topical or systemic medications for acne throughout the study. This includes, but is not limited to, benzoyl peroxide, antibiotics, topical Vitamin A derivatives such as Retin-A.
- Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study.
- Facial surgery (dermabrasion, laser resurfacing or other facial cosmetic surgeries) within 3 months of baseline and throughout the study.
- A history of hypersensitivity to dapsone, parabens, or any component of the study products.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
DermResearch, Inc.
Austin, Texas, 78759
Okatie Research Center, LLC
Beaufort, South Carolina, 29907'
DiscoveResearch, Inc.
Beaumont, Texas, 77701
Radiant Research, Inc.
Birmingham, Alabama, 35209
Boston Clinical Trials
Boston, Massachusetts, 02135
Department of Dermatology SUNY Downstate Medical Center
Brooklyn, New York, 11203
J&S Studies, Inc.
Bryan, Texas, 77802
Metrolina Medical Research
Charlotte, North Carolina, 28209
Universtiy Dermatology Consultants, Inc.
Cincinnati, Ohio, 45219
Research Across America
Dallas, Texas, 75234
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37917
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501
FXM Research
Miami, Florida, 33175
Advanced Healthcare, SC
Milwaukee, Wisconsin, 53209
Dermatology Research Associates
Nashville, Tennessee, 37203
Columbia University Medical Center Department of Dermatology
New York, New York, 10032
MedaPhase, Inc.
Newnan, Georgia, 30263
Virginia Clinical Research
Norfolk, Virginia, 23507
Skin Specialists, PC
Omaha, Nebraska, 68144
University Clinical Research, Inc
Pembroke Pines, Florida, 33024
Paddington Testing Clinic
Philadelphia, Pennsylvania, 19103
Society Hill Dermatology
Philadelphia, Pennsylvania, 19107-6129
Therapeutics Clinical Research
San Diego, California, 92123
Department of Dermatology, University of California, San Francisco
San Francisco, California, 94115
Washington University Dermatology Clinical Trials Unit
St Louis, Missouri, 63110
Dermatology Associates, PC at the Washington Hospital Center
Washington D.C., District of Columbia, 20010
Howard University Hospital Department of Dermatology
Washington D.C., District of Columbia, 20060
About this study
Official title: ACZ ACN 01. A Phase 4, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD-Deficient Subjects With Acne Vulgaris Treated With ACZONE™ (Dapsone) Gel, 5%.
The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders.
ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and was shown to reduce the number of pimples and improve acne.
Read more
The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called "G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher chance of side effects with dapsone.
G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to function normally. Some people have less G6PD in their red blood cells than the average person. This is called G6PD deficiency.
Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.
Read the detailed description
Study Objectives:
- To compare the safety profile and risk of hemolysis of ACZONE Gel, 5% to that of the vehicle after 12 weeks each of twice daily applications in acne vulgaris subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- To determine the systemic levels of plasma dapsone and N-acetyl dapsone during treatment with ACZONE Gel, 5%.
Study Population:
Approximately 60 male and female subjects
Study Treatment:
All subjects in the study will receive ACZONE Gel, 5% and vehicle in 1 of 2 sequences; each for a 12-week period.
- Conditions
- Acne Vulgaris
- Being tested
- ACZONE Gel, 5%, Vehicle
- Keywords
- Acne, G6PD deficiency, Dapsone
- Medical subject headings
- Acne Vulgaris, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZONE Gel, 5%Drug
VehicleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The within-subject between treatment period differences in change from baseline to the 2nd week of each treatment period and change from baseline to the end of each treatment period will be summarized based upon various lab parameters.
The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.
Secondary outcomes (1)
Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Garrett, MS, DDS, Study director, QLT USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243542
- Sponsor's protocol ID
- ACZ ACN 01
- Status last verified
- May 2011
- First submitted
- 21 Oct 2005
- Last updated
- 30 May 2011
- Results posted
- No
Publications
Piette WW, Taylor S, Pariser D, Jarratt M, Sheth P, Wilson D. Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. Arch Dermatol. 2008 Dec;144(12):1564-70. doi: 10.1001/archdermatol.2008.518.
PubMed 19075138
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACZ ACN 01. A Phase 4, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD-Deficient Subjects With Acne Vulgaris Treated With ACZONE™ (Dapsone) Gel, 5%.
- ClinicalTrials.gov ID
- NCT00243542
- Acronym / sponsor ID
- ACZ ACN 01
- Conditions
- Acne Vulgaris
- Keywords
- Acne, G6PD deficiency, Dapsone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 24 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders.
ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and was shown to reduce the number of pimples and improve acne.
The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called "G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher chance of side effects with dapsone.
G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to function normally. Some people have less G6PD in their red blood cells than the average person. This is called G6PD deficiency.
Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.
Detailed description
Study Objectives:
- To compare the safety profile and risk of hemolysis of ACZONE Gel, 5% to that of the vehicle after 12 weeks each of twice daily applications in acne vulgaris subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- To determine the systemic levels of plasma dapsone and N-acetyl dapsone during treatment with ACZONE Gel, 5%.
Study Population:
Approximately 60 male and female subjects
Study Treatment:
All subjects in the study will receive ACZONE Gel, 5% and vehicle in 1 of 2 sequences; each for a 12-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥12 years of age.
- A clear diagnosis of acne vulgaris, defined as ≥20 acne inflammatory and/or non-inflammatory lesions (≥10 of the acne lesions must be on the face, the others may be present on the neck, shoulders, upper chest, and upper back) at screening.
- A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal for the central reference laboratory.
Key exclusion criteria (8 listed)
- A dermal examination reveals the presence of severe cystic acne or acne conglobata.
- Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study.
- Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer.
- Subjects who are using topical or systemic medications for acne throughout the study. This includes, but is not limited to, benzoyl peroxide, antibiotics, topical Vitamin A derivatives such as Retin-A.
- Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study.
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 |
|---|---|---|
| ACZONE Gel, 5% | Drug | – |
| Vehicle | Drug | – |
Primary outcome
The within-subject between treatment period differences in change from baseline to the 2nd week of each treatment period and change from baseline to the end of each treatment period will be summarized based upon various lab parameters.
The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.
1 secondary outcome
Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
- Derived from this study: PubMed 19075138Piette WW, Taylor S, Pariser D, Jarratt M, Sheth P, Wilson D. Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. Arch Dermatol. 2008 Dec;144(12):1564-70. doi: 10.1001/archdermatol.2008.518.
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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.
Steven Garrett, MS, DDS study director
QLT USA, Inc.
29 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 ACZONE Gel, 5% in people with Acne Vulgaris, run by Allergan at 29 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 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The within-subject between treatment period differences in change from baseline to the 2nd week of each treatment period and change from baseline to the end of each treatment period will be summarized based upon various lab parameters.. The study lists 3 primary outcomes in all. 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 NCT00243542, which also lists 1 linked publication.
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 30 May 2011.