AcnePhase 3NCT01135069
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
A Phase 3 study testing Tretinoin microsphere 0.1% and Brand Retin-A Micro tretinoin microsphere gel 0.1% in people with Acne, run by Spear Pharmaceuticals at 1 site in United States.
Trial summary
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Tretinoin microsphere 0.1% and Brand Retin-A Micro tretinoin microsphere gel 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 2010
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normal, healthy male and female children and adult
- Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.
- Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.
- Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
- Considered reliable and capable of understanding their responsibility and role in the study.
Who cannot join
- Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
- Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
- Use topical acne therapy during the two week period prior to study initiation.
- Use of systemic retinoid treatment within six months prior to study initiation.
- Pregnant or breast-feeding.
- Serious psychological illness.
- Participation in any clinical research study during the 30 day period preceding study initiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moore Clinical Research
Land O' Lakes, Florida, 34628
About this study
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
Read the detailed description
Not required
- Conditions
- Acne
- Being tested
- Tretinoin microsphere 0.1%, Brand Retin-A Micro tretinoin microsphere gel 0.1%, placebo microsphere 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.
Tretinoin microsphere 0.1%Drug
Treatment of acne vulgaris
Brand Retin-A Micro tretinoin microsphere gel 0.1%Drug
Also called Retin-A Micro
Treatment of acne vulgaris
placebo microsphere gelDrug
treatment of acne vulgaris
| Study group | Role | What they receive |
|---|---|---|
| Generic | Active comparator | treatment of acne for 12 weeks Receives: Drug: Tretinoin microsphere 0.1% |
| Brand | Active comparator | Treatment of acne for 12 weeks Receives: Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1% |
| Placebo | Placebo comparator | Treatment if acne for 12 weeks as placebo Receives: Drug: placebo microsphere gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Acne
Counting of acne lesions both inflammatory and non-inflammatory
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 posted2 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spear Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krunal Patel, MD, Principal investigator, Moore Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135069
- Sponsor's protocol ID
- RAM-01
- Status last verified
- Oct 2014
- First submitted
- 28 May 2010
- Last updated
- 27 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
- ClinicalTrials.gov ID
- NCT01135069
- Acronym / sponsor ID
- RAM-01
- Conditions
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Spear PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 16 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
Detailed description
Not required
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generic | Active comparator | Drug: Tretinoin microsphere 0.1%treatment of acne for 12 weeks |
| Brand | Active comparator | Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%Treatment of acne for 12 weeks |
| Placebo | Placebo comparator | Drug: placebo microsphere gelTreatment if acne for 12 weeks as placebo |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Normal, healthy male and female children and adult
- Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.
- Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.
- Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
- Considered reliable and capable of understanding their responsibility and role in the study.
Key exclusion criteria (7 listed)
- Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
- Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
- Use topical acne therapy during the two week period prior to study initiation.
- Use of systemic retinoid treatment within six months prior to study initiation.
- Pregnant or breast-feeding.
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 |
|---|---|---|
| Tretinoin microsphere 0.1%Treatment of acne vulgaris | Drug | Generic |
| Brand Retin-A Micro tretinoin microsphere gel 0.1%Also: Retin-A MicroTreatment of acne vulgaris | Drug | Brand |
| placebo microsphere geltreatment of acne vulgaris | Drug | Placebo |
Primary outcome
Improvement in Acne
Time frame: 12 weeks
Counting of acne lesions both inflammatory and non-inflammatory
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- 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.
Krunal Patel, MD principal investigator
Moore Clinical Research
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 Tretinoin microsphere 0.1% and Brand Retin-A Micro tretinoin microsphere gel 0.1% in people with Acne, run by Spear Pharmaceuticals 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 7 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 27 Oct 2014. 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 Oct 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?
Improvement in Acne (time frame: 12 weeks). 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 27 Oct 2014.