Acne VulgarisPhase 1NCT01425320
Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne
A Phase 1 study testing Fixed Combination dapsone/adapalene Formulation A Gel, Fixed Combination dapsone/adapalene Formulation B Gel and dapsone 5% gel in people with Acne Vulgaris, run by Allergan.
Trial summary
This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Fixed Combination dapsone/adapalene Formulation A Gel, Fixed Combination dapsone/adapalene Formulation B Gel and dapsone 5% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 1
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate acne on the face
- Willing to avoid swimming during the study
- Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study
- Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study
Who cannot join
- Severe cystic acne
- Use of topical or oral retinoids within 4 weeks
- Use of isotretinoin within 3 months
- Use of dapsone or adapalene within 3 months
- Anticipated need to engage in activities/exercise that would cause profuse sweating
- Donated blood or equivalent blood loss within 90 days
About this study
This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Fixed Combination dapsone/adapalene Formulation A Gel, Fixed Combination dapsone/adapalene Formulation B Gel, dapsone 5% gel, adapalene 0.3% 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.
Fixed Combination dapsone/adapalene Formulation A GelDrug
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
Fixed Combination dapsone/adapalene Formulation B GelDrug
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
dapsone 5% gelDrug
Also called ACZONE®
Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
adapalene 0.3% gelDrug
Also called Differin®
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Combination dapsone/adapalene Formulation A Gel | Experimental | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. Receives: Drug: Fixed Combination dapsone/adapalene Formulation A Gel |
| Fixed Combination dapsone/adapalene Formulation B Gel | Experimental | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. Receives: Drug: Fixed Combination dapsone/adapalene Formulation B Gel |
| dapsone 5% gel (ACZONE®) | Active comparator | Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders. Receives: Drug: dapsone 5% gel |
| adapalene 0.3% gel (Differin®) | Active comparator | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. Receives: Drug: adapalene 0.3% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Levels of Dapsone
Measured: Day 1
Plasma Levels of Dapsone
Measured: Day 14
Plasma Levels of Adapalene
Measured: Day 1
Plasma Levels of Adapalene
Measured: Day 14
Secondary outcomes (1)
Local Dermal Tolerability Rating Using a 4-Point Scale
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startJan 2013
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.
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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425320
- Sponsor's protocol ID
- 225678-003
- Status last verified
- Nov 2012
- First submitted
- 26 Aug 2011
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne
- ClinicalTrials.gov ID
- NCT01425320
- Acronym / sponsor ID
- 225678-003
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 30 Aug 2011 (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.
This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fixed Combination dapsone/adapalene Formulation A Gel | Experimental | Drug: Fixed Combination dapsone/adapalene Formulation A GelStudy medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
| Fixed Combination dapsone/adapalene Formulation B Gel | Experimental | Drug: Fixed Combination dapsone/adapalene Formulation B GelStudy medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
| dapsone 5% gel (ACZONE®) | Active comparator | Drug: dapsone 5% gelStudy medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders. |
| adapalene 0.3% gel (Differin®) | Active comparator | Drug: adapalene 0.3% gelStudy medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Moderate acne on the face
- Willing to avoid swimming during the study
- Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study
- Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study
Key exclusion criteria (6 listed)
- Severe cystic acne
- Use of topical or oral retinoids within 4 weeks
- Use of isotretinoin within 3 months
- Use of dapsone or adapalene within 3 months
- Anticipated need to engage in activities/exercise that would cause profuse sweating
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 |
|---|---|---|
| Fixed Combination dapsone/adapalene Formulation A GelStudy medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug | Fixed Combination dapsone/adapalene Formulation A Gel |
| Fixed Combination dapsone/adapalene Formulation B GelStudy medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug | Fixed Combination dapsone/adapalene Formulation B Gel |
| dapsone 5% gelAlso: ACZONE®Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug | dapsone 5% gel (ACZONE®) |
| adapalene 0.3% gelAlso: Differin®Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug | adapalene 0.3% gel (Differin®) |
Primary outcome
Plasma Levels of Dapsone
Time frame: Day 1
Plasma Levels of Dapsone
Time frame: Day 14
Plasma Levels of Adapalene
Time frame: Day 1
Plasma Levels of Adapalene
Time frame: Day 14
1 secondary outcome
Local Dermal Tolerability Rating Using a 4-Point Scale
Time frame: Day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
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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.
Medical Director study director
Allergan
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fixed Combination dapsone/adapalene Formulation A Gel, Fixed Combination dapsone/adapalene Formulation B Gel and dapsone 5% gel 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Nov 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Plasma Levels of Dapsone (time frame: Day 1). The study lists 4 primary outcomes in all. 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 19 Nov 2012.