Acne VulgarisPhase 3NCT02865005
Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
A Phase 3 study testing Dapsone 5.0% Gel (SEEGPharm) and Dapsone 5.0% Gel (Allergan) in people with Acne Vulgaris, run by Seegpharm S.A. at 36 sites in 2 countries.
Trial summary
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Dapsone 5.0% Gel (SEEGPharm) and Dapsone 5.0% Gel (Allergan)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,361 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Feb 2016to Dec 2016
- 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 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
- Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization.
- On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation.
- Subjects must have an acne severity grade of 3 or 4 per the IGA
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.
Who cannot join
- Prior or current concomitant therapies that would interfere with assessments in the study.
- Prior or current concomitant therapies skin conditions that would interfere with assessments in the study.
- Prior, current or planned procedures that would interfere with assessments in the study.
- Current or planned activities that would interfere with assessment in the study.
- Subjects who have a Baseline local skin site reaction score of 3 [severe (marked/intense)] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States35 sites
Catawba Clinical Research
Austin, Texas, 78746
Catawba Clinical Research
Boca Raton, Florida, 33486
Catawba Clinical Research
Brandon, Florida, 33511
Catawba Clinical Research
Cincinnati, Ohio, 45246
Catawba Clinical Research
El Paso, Texas, 79902
Catawba Clinical Research
Encino, California, 91436
Catawba Clinical Research
Endwell, New York, 13760
Catawba Clinical Research
Fullerton, California, 92835
Catawba Clinical Research
Hialeah, Florida, 33016
Catawba Clinical Research
High Point, North Carolina, 27262
Catawba Clinical Research
Jenkintown, Pennsylvania, 19046
Catawba Clinical Research
La Mesa, California, 91942
Catawba Clinical Research
Las Vegas, Nevada, 89106
Catawba Clinical Research
Las Vegas, Nevada, 89109
Catawba Clinical Research
Las Vegas, Nevada, 89119
Catawba Clinical Research
Los Angeles, California, 90017
Catawba Clinical Research
Los Angeles, California, 90036
Catawba Clinical Research
Mesquite, Texas, 75149
Catawba Clinical Research
Miami, Florida, 33175
Catawba Clinical Research
Miramar, Florida, 33027
Catawba Clinical Research
Nashville, Tennessee, 37215
Catawba Clinical Research
New Orleans, Louisiana, 70130
Catawba Clinical Research
New York, New York, 10012
Catawba Clinical Research
Norfolk, Nebraska, 68701
Catawba Clinical Research
Norfolk, Virginia, 23507
Catawba Clinical Research
Omaha, Nebraska, 68134
Catawba Clinical Research
Richland, Washington, 97030
Catawba Clinical Research
Savannah, Georgia, 31406
Catawba Clinical Research
Sherman Oaks, California, 91403
Catawba Clinical Research
South Tampa, Florida, 33609
Catawba Clinical Research
Tampa, Florida, 33618
Catawba Clinical Research
Temecula, California, 92592
Catawba Clinical Research
Upper Saint Clair, Pennsylvania, 15241
Catawba Clinical Research
Warminster, Pennsylvania, 18974
Catawba Clinical Research
Wilmington, North Carolina, 28405
Belize1 site
Catawba Clinical Research
Belize City
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Dapsone 5% Gel (SEEGPharm SA) to Aczone® and Both Active Treatments Compared to Placebo (Vehicle) in the Treatment of Acne Vulgaris
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.
Read the detailed description
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.
- Conditions
- Acne Vulgaris
- Being tested
- Dapsone 5.0% Gel (SEEGPharm), Placebo, Dapsone 5.0% Gel (Allergan)
- 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 5.0% Gel (SEEGPharm)Drug
Also called Experimental Arm
Topical Gel
PlaceboOther
Also called Placebo Comparator
Topical Gel
Dapsone 5.0% Gel (Allergan)Drug
Also called Active Comparator
Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| Dapsone 5.0% Gel (Allergan) | Active comparator | Dapsone 5.0% Gel applied twice daily for 84 days Receives: Drug: Dapsone 5.0% Gel (Allergan) |
| Dapsone 5.0% Gel (SEEGPharm) | Experimental | Dapsone 5.0% Gel applied twice daily for 84 days Receives: Drug: Dapsone 5.0% Gel (SEEGPharm) |
| Placebo | Placebo comparator | Vehicle of Experimental Gel applied twice daily for 84 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
To compare Dapsone 5% Gel (SEEGPharm) to Aczone® (Allergan's Dapsone 5% Gel) to the Placebo-Vehicle control with respect to the mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts, from Baseline (Visit 1/ Day1) to End-of-Treatment (EOT)
Measured: Treatment Days: 84 days of dosing
Secondary outcomes (1)
Clinical Success: Proportion of subjects with a clinical response of "success"
To evaluate as the proportion of subjects with a clinical response of "success" at Week 12.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionDec 2016
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seegpharm S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Lewis, MS, Study director, Catawba Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865005
- Sponsor's protocol ID
- SEEG-2015-6-23
- Status last verified
- Dec 2016
- First submitted
- 1 Jul 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Dapsone 5% Gel (SEEGPharm SA) to Aczone® and Both Active Treatments Compared to Placebo (Vehicle) in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02865005
- Acronym / sponsor ID
- SEEG-2015-6-23
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,361 participants (actual)
- Lead sponsor
- Seegpharm S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Aug 2016 (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.
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.
Detailed description
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapsone 5.0% Gel (Allergan) | Active comparator | Drug: Dapsone 5.0% Gel (Allergan)Dapsone 5.0% Gel applied twice daily for 84 days |
| Dapsone 5.0% Gel (SEEGPharm) | Experimental | Drug: Dapsone 5.0% Gel (SEEGPharm)Dapsone 5.0% Gel applied twice daily for 84 days |
| Placebo | Placebo comparator | Other: PlaceboVehicle of Experimental Gel applied twice daily for 84 days |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
- Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization.
- On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation.
- Subjects must have an acne severity grade of 3 or 4 per the IGA
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.
Key exclusion criteria (5 listed)
- Prior or current concomitant therapies that would interfere with assessments in the study.
- Prior or current concomitant therapies skin conditions that would interfere with assessments in the study.
- Prior, current or planned procedures that would interfere with assessments in the study.
- Current or planned activities that would interfere with assessment in the study.
- Subjects who have a Baseline local skin site reaction score of 3 [severe (marked/intense)] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.
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 5.0% Gel (SEEGPharm)Also: Experimental ArmTopical Gel | Drug | Dapsone 5.0% Gel (SEEGPharm) |
| PlaceboAlso: Placebo ComparatorTopical Gel | Other | Placebo |
| Dapsone 5.0% Gel (Allergan)Also: Active ComparatorTopical Gel | Drug | Dapsone 5.0% Gel (Allergan) |
Primary outcome
Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
Time frame: Treatment Days: 84 days of dosing
To compare Dapsone 5% Gel (SEEGPharm) to Aczone® (Allergan's Dapsone 5% Gel) to the Placebo-Vehicle control with respect to the mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts, from Baseline (Visit 1/ Day1) to End-of-Treatment (EOT)
1 secondary outcome
Clinical Success: Proportion of subjects with a clinical response of "success"
Time frame: 12 Weeks
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 20 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Karen Lewis, MS study director
Catawba Clinical Research
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapsone 5.0% Gel (SEEGPharm) and Dapsone 5.0% Gel (Allergan) in people with Acne Vulgaris, run by Seegpharm S.A. at 36 sites in 2 countries.
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 5 inclusion and 5 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 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Belize. 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. Some participants in this study may receive a placebo. 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?
Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts (time frame: Treatment Days: 84 days of dosing). 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 20 Dec 2016.