AcnePhase 3NCT02525549
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
A Phase 3 study testing Adapalene and Benzoyl Peroxide Gel and Adapalene and Benzoyl Peroxide Gel (Reference) in people with Acne, run by Padagis LLC.
Trial summary
The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne
- What is being tested?
- Adapalene and Benzoyl Peroxide Gel and Adapalene and Benzoyl Peroxide Gel (Reference)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 903 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Aug 2012
- Phase
- Phase 3
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and non-pregnant female subjects, 12 to 40 years of age (inclusive), with a clinical diagnosis of at least moderate facial acne vulgaris
- Inflammatory lesion (papules and pustules) count of 20 to 50 (inclusive)
- Non-inflammatory (open and closed comedones) lesion count of 25 to 100 (inclusive)
- No more than two nodulocystic lesions (i.e., nodules and cysts) on the face including those present on the nose, were enrolled.
- Subjects must also have had a Baseline IGA score of 3 or 4 on a severity scale of 0 to 4 to be enrolled.
Who cannot join
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Presence of more than 2 facial Nodulocystic lesions (i.e. nodules and cysts)
- Subjects with active cystic acne or Polycystic Ovarian Syndrome
- Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations (e .g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculiti s).
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- Acne conglobata, acne fulminan s, or secondary acne (chloracne, drug-induced acne, etc.)
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- Use of antipruritics including antihistamine, within 24 hours prior to all study visits (Visit l/Baseline through Visit 4).
- Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days of study entry and throughout the study (other than study supplied cleanser and lotion).
- Use within 6 months prior to baseline or during the study of oral retinoids (e.g. Accutane"') or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- Use within 1 month prior to baseline or during the study of therapeutic vitamin D supplement (multivitamins are allowed).
- Use within 1 month prior to baseline or during the study of 1) systemic sterOids', 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or 4) systemic anti-inflammatory agents". (' Intranasal and inhaled corticosteroids do not require a washout and may be used throughout the study if at a stable and standard dose. "Subjects may use Acetaminophen for pain relief, as needed, throughout the study)
- Use within 14 days prior to baseline or during the study of 1) topical sterOids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparation (e.g. azelaic acid,etc.) 4)a-hydroxy/glycolic acid, 5) benzoyl peroxide, 6) topical anti-inflammatory agents, or 7) topical antibiotics.
About this study
The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris.
- Conditions
- Acne
- Being tested
- Adapalene and Benzoyl Peroxide Gel, Adapalene and Benzoyl Peroxide Gel (Reference), Placebo 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.
Adapalene and Benzoyl Peroxide GelDrug
Adapalene and Benzoyl Peroxide Gel (Reference)Drug
Placebo gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Adapalene and Benzoyl Peroxide Gel Receives: Drug: Adapalene and Benzoyl Peroxide Gel |
| Reference product | Active comparator | Adapalene and Benzoyl Peroxide Gel (Reference) Receives: Drug: Adapalene and Benzoyl Peroxide Gel (Reference) |
| Placebo product | Placebo comparator | Placebo gel Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
Measured: 84 days
Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionAug 2012
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.
- Other trials for AcneStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525549
- Sponsor's protocol ID
- PRG-817
- Status last verified
- Oct 2021
- First submitted
- 14 Aug 2015
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02525549
- Acronym / sponsor ID
- PRG-817
- Conditions
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 20 Jan 2021
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 bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: Adapalene and Benzoyl Peroxide GelAdapalene and Benzoyl Peroxide Gel |
| Reference product | Active comparator | Drug: Adapalene and Benzoyl Peroxide Gel (Reference)Adapalene and Benzoyl Peroxide Gel (Reference) |
| Placebo product | Placebo comparator | Drug: Placebo gelPlacebo gel |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male and non-pregnant female subjects, 12 to 40 years of age (inclusive), with a clinical diagnosis of at least moderate facial acne vulgaris
- Inflammatory lesion (papules and pustules) count of 20 to 50 (inclusive)
- Non-inflammatory (open and closed comedones) lesion count of 25 to 100 (inclusive)
- No more than two nodulocystic lesions (i.e., nodules and cysts) on the face including those present on the nose, were enrolled.
- Subjects must also have had a Baseline IGA score of 3 or 4 on a severity scale of 0 to 4 to be enrolled.
Key exclusion criteria (12 listed)
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Presence of more than 2 facial Nodulocystic lesions (i.e. nodules and cysts)
- Subjects with active cystic acne or Polycystic Ovarian Syndrome
- Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations (e .g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculiti s).
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
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 |
|---|---|---|
| Adapalene and Benzoyl Peroxide Gel | Drug | Test product |
| Adapalene and Benzoyl Peroxide Gel (Reference) | Drug | Reference product |
| Placebo gel | Drug | Placebo product |
Primary outcome
Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
Time frame: 84 days
Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions
Time frame: 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene and Benzoyl Peroxide Gel and Adapalene and Benzoyl Peroxide Gel (Reference) in people with Acne, run by Padagis LLC.
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 12 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 2 Nov 2021. 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. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2021). 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?
Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions (time frame: 84 days). The study lists 2 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 2 Nov 2021.