Acne VulgarisPhase 1NCT01785836
An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris
A Phase 1 study testing Dapsone Formulation A, Dapsone Formulation B and Dapsone Formulation C in people with Acne Vulgaris, run by Allergan.
Trial summary
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Dapsone Formulation A, Dapsone Formulation B and Dapsone Formulation C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Oct 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participation in Allergan study 225678-004
Who cannot join
- Anticipates the need for surgery or hospitalization during the study
About this study
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.
- Conditions
- Acne Vulgaris
- Being tested
- Dapsone Formulation A, Dapsone Formulation B, Dapsone Formulation C, Dapsone 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 Formulation ADrug
Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation BDrug
Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation CDrug
Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone 5% GelDrug
Also called ACZONE®
Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapsone Formulation A | Experimental | Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. Receives: Drug: Dapsone Formulation A |
| Dapsone Formulation B | Experimental | Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. Receives: Drug: Dapsone Formulation B |
| Dapsone Formulation C | Experimental | Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. Receives: Drug: Dapsone Formulation C |
| Dapsone 5% Gel | Active comparator | Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. Receives: Drug: Dapsone 5% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Inflammatory Lesion Count
Measured: Baseline, Week 12
Secondary outcomes (3)
Change from Baseline in Non-Inflammatory Lesion Count
Measured: Baseline, Week 12
Change from Baseline in Total Lesion Count
Measured: Baseline, Week 12
Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013 (estimated)
- Study completionOct 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT01785836
- Sponsor's protocol ID
- 225678-005
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01785836
- Acronym / sponsor ID
- 225678-005
- 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
- Mar 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 7 Feb 2013 (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 assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dapsone Formulation A | Experimental | Drug: Dapsone Formulation ADapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
| Dapsone Formulation B | Experimental | Drug: Dapsone Formulation BDapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
| Dapsone Formulation C | Experimental | Drug: Dapsone Formulation CDapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
| Dapsone 5% Gel | Active comparator | Drug: Dapsone 5% GelDapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participation in Allergan study 225678-004
Key exclusion criteria (1 listed)
- Anticipates the need for surgery or hospitalization 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 |
|---|---|---|
| Dapsone Formulation ADapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug | Dapsone Formulation A |
| Dapsone Formulation BDapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug | Dapsone Formulation B |
| Dapsone Formulation CDapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug | Dapsone Formulation C |
| Dapsone 5% GelAlso: ACZONE®Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug | Dapsone 5% Gel |
Primary outcome
Change from Baseline in Inflammatory Lesion Count
Time frame: Baseline, Week 12
3 secondary outcomes
Change from Baseline in Non-Inflammatory Lesion Count
Time frame: Baseline, Week 12
Change from Baseline in Total Lesion Count
Time frame: Baseline, Week 12
Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1
Time frame: Week 12
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 25 Feb 2013.
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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 Dapsone Formulation A, Dapsone Formulation B and Dapsone Formulation C 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 1 inclusion and 1 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 25 Feb 2013. 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?
Change from Baseline in Inflammatory Lesion Count (time frame: Baseline, Week 12). 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 25 Feb 2013.