Acne VulgarisPhase 3NCT03393494
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
A Phase 3 study testing Adapalene and Benzoyl Peroxide Topical Gel and Epiduo Topical Product in people with Acne Vulgaris, run by Padagis LLC at 1 site in United States.
Trial summary
To compare the safety and efficacy of Perrigo's product to an FDA approved product for 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?
- Adapalene and Benzoyl Peroxide Topical Gel and Epiduo Topical Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 825 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2017to 5 Jan 2019
- 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
- Signed IRB approved written informed consent/assent
- 12 to 40 years of age, inclusive.
- Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.
- Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.
- Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.
Who cannot join
- Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
- Presence of more than 2 facial Nodulocystic lesions.
- Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations
- Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
- Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.
- History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.
Show all 13Show fewer
- Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.
- History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.
- Use of medications known to exacerbate acne
- Start or change within 3 months (90 days) of Visit 1 and throughout the study
- Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study
- Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
- Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consultants
High Point, North Carolina, 27262
About this study
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene and Benzoyl Peroxide Topical Gel, Epiduo Topical Product, Placebo
- 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 Topical GelDrug
Test product
Epiduo Topical ProductDrug
RLD product
PlaceboDrug
Placebo gel
| Study group | Role | What they receive |
|---|---|---|
| Perrigo active | Experimental | Test product Receives: Drug: Adapalene and Benzoyl Peroxide Topical Gel |
| Reference active | Active comparator | RLD product Receives: Drug: Epiduo Topical Product |
| Perrigo placebo | Placebo comparator | placebo product Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in the Papules and Pustules Lesion Count
Measured: Day 1 to week 12
Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count
Per protocol population
Measured: Day 1 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start13 Dec 2017
- Primary completion30 Sep 2018
- Study completion5 Jan 2019
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 825 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
- NCT03393494
- Sponsor's protocol ID
- PRG-NY-17-008
- Status last verified
- Nov 2021
- First submitted
- 3 Jan 2018
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03393494
- Acronym / sponsor ID
- PRG-NY-17-008
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 5 Jan 2019 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of 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 |
|---|---|---|
| Perrigo active | Experimental | Drug: Adapalene and Benzoyl Peroxide Topical GelTest product |
| Reference active | Active comparator | Drug: Epiduo Topical ProductRLD product |
| Perrigo placebo | Placebo comparator | Drug: Placeboplacebo product |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Signed IRB approved written informed consent/assent
- 12 to 40 years of age, inclusive.
- Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.
- Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.
- Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.
Key exclusion criteria (13 listed)
- Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
- Presence of more than 2 facial Nodulocystic lesions.
- Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations
- Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
- Excessive facial hair that would interfere with the 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 Topical GelTest product | Drug | Perrigo active |
| Epiduo Topical ProductRLD product | Drug | Reference active |
| PlaceboPlacebo gel | Drug | Perrigo placebo |
Primary outcome
Mean Percent Change From Baseline in the Papules and Pustules Lesion Count
Time frame: Day 1 to week 12
Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count
Time frame: Day 1 to week 12
Per protocol population
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene and Benzoyl Peroxide Topical Gel and Epiduo Topical Product in people with Acne Vulgaris, run by Padagis LLC 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 5 inclusion and 13 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 8 Nov 2021. 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. 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 5 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 in the Papules and Pustules Lesion Count (time frame: Day 1 to week 12). 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 8 Nov 2021.