Acne VulgarisPhase 1NCT01773122
Safety, Tolerability, and Pharmacokinetics 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 at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing. Read more about this study
- Who is it for?
- Ages 16 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
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2013to 5 May 2013
- Phase
- Phase 1
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of acne vulgaris
- Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
- If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
- willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study
Who cannot join
- Oral acne treatments within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.
- 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, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation BDrug
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation CDrug
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone 5% GelDrug
Also called ACZONE®
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Dapsone Formulation A | Experimental | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. Receives: Drug: Dapsone Formulation A |
| Dapsone Formulation B | Experimental | Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. Receives: Drug: Dapsone Formulation B |
| Dapsone Formulation C | Experimental | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. Receives: Drug: Dapsone Formulation C |
| Dapsone 5% Gel | Active comparator | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. Receives: Drug: Dapsone 5% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Level (Cmax) of Dapsone
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.
Measured: Day 28
Secondary outcomes (1)
Maximum Plasma Level (Cmax) of Dapsone Metabolites
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study start21 Jan 2013
- Primary completion5 May 2013
- Study completion5 May 2013
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.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 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
- NCT01773122
- Sponsor's protocol ID
- 225678-004
- Status last verified
- Apr 2019
- First submitted
- 18 Jan 2013
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jarratt MT, Jones TM, Chang-Lin JE, Tong W, Berk DR, Lin V, Kaoukhov A. Safety and Pharmacokinetics of Once-Daily Dapsone Gel, 7.5% in Patients With Moderate Acne Vulgaris. J Drugs Dermatol. 2016 Oct 1;15(10):1250-1259.
PubMed 27741344
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01773122
- Acronym / sponsor ID
- 225678-004
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2013 (actual)
- Primary completion
- 5 May 2013 (actual)
- Study completion
- 5 May 2013 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 26 Mar 2014
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 evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dapsone Formulation A | Experimental | Drug: Dapsone Formulation ADapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone Formulation B | Experimental | Drug: Dapsone Formulation BDapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone Formulation C | Experimental | Drug: Dapsone Formulation CDapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone 5% Gel | Active comparator | Drug: Dapsone 5% GelDapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of acne vulgaris
- Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
- If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
- willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study
Key exclusion criteria (1 listed)
- Oral acne treatments within 6 months
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, upper chest, upper back, and shoulders for 28 days. | Drug | Dapsone Formulation A |
| Dapsone Formulation BDapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | Drug | Dapsone Formulation B |
| Dapsone Formulation CDapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | Drug | Dapsone Formulation C |
| Dapsone 5% GelAlso: ACZONE®Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. | Drug | Dapsone 5% Gel |
Primary outcome
Maximum Plasma Level (Cmax) of Dapsone
Time frame: Day 28
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.
1 secondary outcome
Maximum Plasma Level (Cmax) of Dapsone Metabolites
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27741344Jarratt MT, Jones TM, Chang-Lin JE, Tong W, Berk DR, Lin V, Kaoukhov A. Safety and Pharmacokinetics of Once-Daily Dapsone Gel, 7.5% in Patients With Moderate Acne Vulgaris. J Drugs Dermatol. 2016 Oct 1;15(10):1250-1259.
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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
1 site in 1 country: see every site and its status.
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 at 1 site 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 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: finished, as of the sponsor's last update on 24 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 1 site 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 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?
Yes. Results are posted in the registry (first posted 26 Mar 2014). 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?
Maximum Plasma Level (Cmax) of Dapsone (time frame: Day 28). 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 NCT01773122, 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 24 Apr 2019.