Acne VulgarisPhase 3NCT00151541
A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4%
A Phase 3 study testing Dapsone Topical Gel + adapalene gel 0.1% and Dapsone Topical Gel + benzoyl peroxide gel 4% in people with Acne Vulgaris, run by Allergan.
Trial summary
The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl peroxide gel 4%. 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?
- Dapsone Topical Gel + adapalene gel 0.1% and Dapsone Topical Gel + benzoyl peroxide gel 4%
- How many people
- 301 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Jul 2005
- Phase
- Phase 3
- 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
- Study subjects will be considered for participation based upon medical history and findings from the pre-study interview and examination. They will be enrolled according to the following conditions:
- Each subject or parent/guardian will read and sign the informed assent and/or consent form as required by IRB regulations. If a subject should require someone to read and/or interpret any or all of the informed consent, a statement of this fact will be documented. If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion to ensure accurate representation of the informed consent document is given verbally. If a subject does not understand English, a validated translated informed consent agreement will be provided. If the subject is a minor, the signature of their parent or guardian will be required per Institutional Review Board regulations.
- Male and female subjects, 12 years of age and older.
- A female subject of childbearing potential must not be pregnant or nursing. All female subjects must be practicing an effective method of birth control as determined by the Investigator. Any female who is not sexually active must agree to begin using an effective method of birth control, excluding hormonal birth control, if she becomes sexually active during the study.
- A female subject using hormonal birth control must have been on a stable dose for 3 months prior to Baseline.
- Note: A surgically sterilized partner is not an acceptable method of birth control.
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- A urine pregnancy test will be required of all female subjects, 60 years of age and younger prior to treatment. If the subject can provide documentation of surgical sterilization, at the baseline visit, a pregnancy test is not required.
- Negative test results must be obtained prior to randomization.
- Subjects must be in good physical and mental health.
- The subject must be willing to avoid swimming and bathing for 2 hours following test article application. Additionally, the subject must be willing to avoid moisturizers, sunscreens and cosmetics for 1 hour following test article application.
- The subject must score > 2 on the Global Acne Assessment Score at Baseline (Appendix D).
- Subjects must have a clear diagnosis of acne vulgaris of the face, and have a minimum of 20 inflammatory lesions (pustules and papules) and 20 non-inflammatory lesions (comedones) above the mandibular line at Baseline. If, in the judgment of the Investigator, the subject's acne should be treated with a systemic acne medication, they should not be enrolled in the study.
- Subjects must be willing to undergo blood draws throughout the study.
- The subject must be willing and able to comply with the requirements of the protocol
Who cannot join
- MEDICATIONS EXCLUDED IN THE ADMISSION CRITERIA WILL NOT BE PERMITTED DURING THE STUDY.
- Subjects who meet any of the following criteria will be excluded from study entry:
- Subjects using systemic immunosuppressive medications within 28 days prior to Baseline and throughout the study. Intranasal and/or inhaled corticosteriods are acceptable throughout the study if at a stable and standard dose, as labeled within the Package Insert.
- Subjects who are using topical agents for acne (including and not limited to benzoyl peroxide, antibiotics, topical vitamin A derivates such as retinol or retinoids, medicated cosmetics, cleansers) within 14 days prior to Baseline and throughout the study. This includes over the counter medications and cleansers that contain acne treatment ingredients, e.g. benzoyl peroxide, salicylic acid.
- Subjects who have received light therapies (ultraviolet B, tanning bed, lasers, photodynamic treatment), systemic medications, or skin treatments known to affect acne or inflammatory responses within the 28 days prior to Baseline and throughout the study. This includes but is not limited to: antibiotics, large doses (>50,000 U/day) of vitamin A, hormones (excluding those used for birth control), spironolactone, aldactone, aldactizide, cyproterone acetate, NSAIDS and chemical exfoliative treatments (alpha-hydroxy acid or "fruit-wash," "lunchtime" or phenol peels) or physical peels (laser, "dry ice" peels). Short-term treatment with antibiotics and NSAIDS during the study for non-acne related conditions is acceptable provided that exposure is limited to 14 days per course for antibiotics and 7 days per month for NSAIDS.
- Subjects who have received isotretinoin (Accutane) within the three months prior to Baseline and throughout the study.
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- Subjects that have participated in any previous QLT USA, Inc. (formerly Atrix Laboratories, Inc.) dapsone topical gel studies.
- Subjects who have any medical condition which, in the Investigator's judgment, makes the subject an inappropriate study candidate.
- Subjects who have any condition that would hinder accurate facial acne evaluations including excessive facial hair (beard), excessive scarring, sunburn or other disfigurement.
- Subjects with severe cystic acne or acne conglobata.
- Subjects with any active or developing nodules above the mandibular line at Baseline.
- Subjects with a known allergy or hypersensitivity to dapsone, adapalene, benzoyl peroxide, or any component of the study products.
- Subjects taking another investigational test article within the 30 days prior to Baseline or throughout the study.
- Female subjects having started a new, or having changed their current hormonal contraceptive or hormone replacement therapy within three months prior to Baseline. Subjects receiving Depo Provera® injections in preceding 4 months are excluded from the study.
About this study
Official title: A Phase 3, Randomized, Double-blind, Multi-dose Study to Evaluate the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG 5%) When Co-administered With Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4% in the Treatment of Acne Vulgaris.
The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
Read the detailed description
This is a 3 arm, 12-week, randomized, double-blind, multicenter study comparing safety and efficacy of DTG 5% twice daily plus vehicle control once daily vs. DTG 5% twice daily plus adapalene gel 0.1% once daily vs. DTG 5% twice daily plus 4% benzoyl peroxide gel once daily in subjects with acne vulgaris. Approximately 300 male and female subjects, 12 years of age and older, with acne vulgaris and > 20 inflammatory lesions (papules and/or pustules) and > 20 non-inflammatory lesions (comedones) above the mandibular line at Baseline will be enrolled. Follow-up visits will occur at Week 2, 4, 8 and 12. Global Acne Assessments, Lesion Counts and Local Adverse Reaction Assessments will be conducted at each visit. A physical exam will be done at Baseline and Week 12. Plasma Dapsone Level samples will be drawn at Baseline, Week 2 and Week 12/ET for dapsone plasma level assessments. Adverse events and concomitant medications will be assessed throughout the study.
- Conditions
- Acne Vulgaris
- Being tested
- Dapsone Topical Gel + adapalene gel 0.1%, Dapsone Topical Gel + benzoyl peroxide gel 4%, Dapsone Topical Gel + vehicle control
- Keywords
- Acne Vulgaris, Acne, Dermatology, Dapsone, Dapsone Topical 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 Topical Gel + adapalene gel 0.1%Drug
Dapsone Topical Gel + benzoyl peroxide gel 4%Drug
Dapsone Topical Gel + vehicle controlDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be mean percent reduction in inflammatory lesion counts.
Secondary outcomes (2)
Additional efficacy endpoints will be the mean percent reduction from Baseline in non-inflammatory and total lesion counts, as well as the proportion of subjects who achieve success (none/minimal) on a 5-point Global Acne Assessment Score.
Safety endpoints will include treatment-emergent and treatment related adverse events. An additional safety endpoint will be the local adverse reaction assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Garrett, MS, DDS, FACS, Study director, QLT USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151541
- Sponsor's protocol ID
- DAP0407
- Status last verified
- May 2011
- First submitted
- 7 Sep 2005
- Last updated
- 30 May 2011
- Results posted
- No
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
- A Phase 3, Randomized, Double-blind, Multi-dose Study to Evaluate the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG 5%) When Co-administered With Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4% in the Treatment of Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT00151541
- Acronym / sponsor ID
- DAP0407
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Acne, Dermatology, Dapsone, Dapsone Topical Gel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 9 Sep 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 compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
Detailed description
This is a 3 arm, 12-week, randomized, double-blind, multicenter study comparing safety and efficacy of DTG 5% twice daily plus vehicle control once daily vs. DTG 5% twice daily plus adapalene gel 0.1% once daily vs. DTG 5% twice daily plus 4% benzoyl peroxide gel once daily in subjects with acne vulgaris. Approximately 300 male and female subjects, 12 years of age and older, with acne vulgaris and > 20 inflammatory lesions (papules and/or pustules) and > 20 non-inflammatory lesions (comedones) above the mandibular line at Baseline will be enrolled. Follow-up visits will occur at Week 2, 4, 8 and 12. Global Acne Assessments, Lesion Counts and Local Adverse Reaction Assessments will be conducted at each visit. A physical exam will be done at Baseline and Week 12. Plasma Dapsone Level samples will be drawn at Baseline, Week 2 and Week 12/ET for dapsone plasma level assessments. Adverse events and concomitant medications will be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (14 listed)
- Study subjects will be considered for participation based upon medical history and findings from the pre-study interview and examination. They will be enrolled according to the following conditions:
- Each subject or parent/guardian will read and sign the informed assent and/or consent form as required by IRB regulations. If a subject should require someone to read and/or interpret any or all of the informed consent, a statement of this fact will be documented. If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion to ensure accurate representation of the informed consent document is given verbally. If a subject does not understand English, a validated translated informed consent agreement will be provided. If the subject is a minor, the signature of their parent or guardian will be required per Institutional Review Board regulations.
- Male and female subjects, 12 years of age and older.
- A female subject of childbearing potential must not be pregnant or nursing. All female subjects must be practicing an effective method of birth control as determined by the Investigator. Any female who is not sexually active must agree to begin using an effective method of birth control, excluding hormonal birth control, if she becomes sexually active during the study.
- A female subject using hormonal birth control must have been on a stable dose for 3 months prior to Baseline.
Key exclusion criteria (14 listed)
- MEDICATIONS EXCLUDED IN THE ADMISSION CRITERIA WILL NOT BE PERMITTED DURING THE STUDY.
- Subjects using systemic immunosuppressive medications within 28 days prior to Baseline and throughout the study. Intranasal and/or inhaled corticosteriods are acceptable throughout the study if at a stable and standard dose, as labeled within the Package Insert.
- Subjects who are using topical agents for acne (including and not limited to benzoyl peroxide, antibiotics, topical vitamin A derivates such as retinol or retinoids, medicated cosmetics, cleansers) within 14 days prior to Baseline and throughout the study. This includes over the counter medications and cleansers that contain acne treatment ingredients, e.g. benzoyl peroxide, salicylic acid.
- Subjects who have received light therapies (ultraviolet B, tanning bed, lasers, photodynamic treatment), systemic medications, or skin treatments known to affect acne or inflammatory responses within the 28 days prior to Baseline and throughout the study. This includes but is not limited to: antibiotics, large doses (>50,000 U/day) of vitamin A, hormones (excluding those used for birth control), spironolactone, aldactone, aldactizide, cyproterone acetate, NSAIDS and chemical exfoliative treatments (alpha-hydroxy acid or "fruit-wash," "lunchtime" or phenol peels) or physical peels (laser, "dry ice" peels). Short-term treatment with antibiotics and NSAIDS during the study for non-acne related conditions is acceptable provided that exposure is limited to 14 days per course for antibiotics and 7 days per month for NSAIDS.
- Subjects who have received isotretinoin (Accutane) within the three months prior to Baseline and throughout 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 |
|---|---|---|
| Dapsone Topical Gel + adapalene gel 0.1% | Drug | – |
| Dapsone Topical Gel + benzoyl peroxide gel 4% | Drug | – |
| Dapsone Topical Gel + vehicle control | Drug | – |
Primary outcome
The primary efficacy endpoint will be mean percent reduction in inflammatory lesion counts.
2 secondary outcomes
Additional efficacy endpoints will be the mean percent reduction from Baseline in non-inflammatory and total lesion counts, as well as the proportion of subjects who achieve success (none/minimal) on a 5-point Global Acne Assessment Score.
Safety endpoints will include treatment-emergent and treatment related adverse events. An additional safety endpoint will be the local adverse reaction assessment.
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.
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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, FACS study director
QLT USA, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapsone Topical Gel + adapalene gel 0.1% and Dapsone Topical Gel + benzoyl peroxide gel 4% in people with Acne Vulgaris, run by Allergan.
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 14 inclusion and 14 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.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 primary efficacy endpoint will be mean percent reduction in inflammatory lesion counts.. 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 30 May 2011.