AcnePhase 3NCT02515305
Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne Vulgaris
A Phase 3 study testing Clindamycin and Benzoyl Peroxide Gel (combination) and Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) in people with Acne, run by Padagis LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy 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?
- Clindamycin and Benzoyl Peroxide Gel (combination) and Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 890 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2016
- 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
- Provide written informed consent/assent
- Healthy male or non-pregnant females, 12 to 40 years of age, inclusive
- Definite clinical diagnosis of acne vulgaris with an inflammatory lesion (papules and pustules) count between 20 and 50 and a non-inflammatory (open and closed comedones) lesion count between 25 and 100 and no more than 2 nodulocystic lesions (i.e., nodules and cysts) including those present on the nose.
- Baseline IGA score of 3 or 4 on a scale of 0 to 4.
- Willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other topical acne medication or topical antibiotics during the 12-week treatment period, return for the required treatment period visits, comply with therapy prohibitions, and are able to complete the study.
- Be in general good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
- Females of childbearing potential willing to use an acceptable form of birth control
Who cannot join
- Females who are pregnant, nursing, or planning a pregnancy within the study participation period
- More than 2 facial nodulocystic lesions (i.e. nodules and cysts).
- Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
- Active cystic acne or Polycystic Ovarian Syndrome.
- History or presence of Crohn's disease, ulcerative colitis, regional enteritis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea or antibiotic-associated colitis.
- Use of neuromuscular blocking agents (nondepolarizing agents and depolarizing agents) Subjects who have had general anesthesia for any reason and subjects who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation.
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- Presence of any other facial skin condition that might interfere with acne vulgaris diagnosis and/or assessment (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, sunburn or bacterial folliculitis).
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- History of unresponsiveness to topical Clindamycin Phosphate and/or benzoyl peroxide therapy.
- Use of systemic Clindamycin products 4 weeks (30 days) prior to baseline or throughout the study.
- History of hypersensitivity or allergy to Clindamycin Phosphate, benzoyl peroxide and/or any ingredient in the study medication.
- Use within 6 months (180 days) 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 of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
- Use within 30 days (1 month) prior to baseline or during the study of therapeutic vitamin D supplement (daily multivitamins with total 800IU Vitamin D are allowed).
- Use of medications known to exacerbate acne (Vitamin B12, lithium, corticosteroids; Vitamin B12, etc. as part of a multivitamin regimen is allowed).
- Start or change of dose of hormonal treatment (oral, implanted, topical contraceptives and androgens) 3 months (90 days) prior to baseline or throughout the study. Use of such therapy must remain constant during 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 (other than study supplied cleanser and lotion).
- Use within 30 days (1 month) prior to baseline or during the study of 1) spironolactone, 2) systemic steroids*, 3) systemic (e.g., oral or injectable) antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or 5) immunosuppressive 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 systemic anti-inflammatory agents (i.e., NSAIDs (Ibuprofen or Aspirin) for pain relief) as needed (with no more than 7 days of consecutive use) throughout the study. Prophylactic use of low dose Aspirin 81 mg is allowed. *** Subjects may use Acetaminophen for pain relief, as needed throughout the study
- Use within 14 days (2 weeks) prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical anti-acne medications (e.g. Benzoyl peroxide, retinoids, azelaic acid, α-hydroxy/glycolic acid, Clindamycin, etc.) including OTC preparations 4) topical anti-inflammatory agents, or 5) topical antibiotics.
- Use on the face within 1 month (30 days) prior to baseline or during the study of 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
- Use of medicated cleansers (e.g. benzoyl peroxide, salicylic acid, sulfur or triclosan) within 2 weeks (14 days) of study start 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.
- Use of Antipruritics, including antihistamines within 24 hours (1day) of all study visits (Visit 1 through Visit 4).
- Participation in any clinical study involving an investigational product, agent or device ( that might influence the intended effects or mask the side effects of study medication ) in the 4 weeks (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.
- Previous enrollment in this study or current enrollment in this study at another participating site.
- Employee (or employee's family member) of the research center or private practice, or subjects who have a conflict of interest.
- Use of tanning booths, sun lamps, sunbathing or excessive exposure to the sun 1 week (7 days) prior to enrollment and throughout the study.
- 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
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
The purpose of this study is to compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment acne vulgaris
- Conditions
- Acne
- Being tested
- Clindamycin and Benzoyl Peroxide Gel (combination), Clindamycin and Benzoyl Peroxide Gel (Reference) (combination), Placebo gel (combination)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin and Benzoyl Peroxide Gel (combination)Drug
Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)Drug
Placebo gel (combination)Drug
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Not described Receives: Drug: Clindamycin and Benzoyl Peroxide Gel (combination) |
| Reference product | Active comparator | Not described Receives: Drug: Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) |
| Placebo product | Placebo comparator | Not described Receives: Drug: Placebo gel (combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions
Measured: Baseline to Day 84
Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions
Measured: Baseline to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionJun 2016
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
- 890 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
- NCT02515305
- Sponsor's protocol ID
- PRG-NY-15-003
- Status last verified
- Nov 2021
- First submitted
- 31 Jul 2015
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
- Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02515305
- Acronym / sponsor ID
- PRG-NY-15-003
- Conditions
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Posted 16 Nov 2020
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 efficacy 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: Clindamycin and Benzoyl Peroxide Gel (combination) |
| Reference product | Active comparator | Drug: Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) |
| Placebo product | Placebo comparator | Drug: Placebo gel (combination) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Provide written informed consent/assent
- Healthy male or non-pregnant females, 12 to 40 years of age, inclusive
- Definite clinical diagnosis of acne vulgaris with an inflammatory lesion (papules and pustules) count between 20 and 50 and a non-inflammatory (open and closed comedones) lesion count between 25 and 100 and no more than 2 nodulocystic lesions (i.e., nodules and cysts) including those present on the nose.
- Baseline IGA score of 3 or 4 on a scale of 0 to 4.
- Willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other topical acne medication or topical antibiotics during the 12-week treatment period, return for the required treatment period visits, comply with therapy prohibitions, and are able to complete the study.
Key exclusion criteria (28 listed)
- Females who are pregnant, nursing, or planning a pregnancy within the study participation period
- More than 2 facial nodulocystic lesions (i.e. nodules and cysts).
- Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
- Active cystic acne or Polycystic Ovarian Syndrome.
- History or presence of Crohn's disease, ulcerative colitis, regional enteritis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea or antibiotic-associated colitis.
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 |
|---|---|---|
| Clindamycin and Benzoyl Peroxide Gel (combination) | Drug | Test product |
| Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) | Drug | Reference product |
| Placebo gel (combination) | Drug | Placebo product |
Primary outcome
Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions
Time frame: Baseline to Day 84
Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions
Time frame: Baseline to Day 84
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 Clindamycin and Benzoyl Peroxide Gel (combination) and Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) in people with Acne, 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 7 inclusion and 28 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 16 Nov 2020). 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 Inflammatory (Papules and Pustules) Lesions (time frame: Baseline to Day 84). 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.