AcnePhase 3NCT01243450
Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
A Phase 3 study testing Tretinoin 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 958 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 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
None listed.
Who cannot join
- A subject will be eligible to participate if they meet none of the following exclusion criteria:
- Subjects with active cystic acne as evidenced by more than 2 facial nodules.
- More than 40 papules and/or pustules (inflammatory lesions)
- More than 60 open and or closed comedones/milia (non-inflammatory lesions)
- Overall severity grade of less than 2 or greater than 4,
- History of allergy or hypersensitivity to tretinoin.
Show all 11Show fewer
- Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
- Use of systemic retinoid treatment within six months prior to study initiation.
- Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
- Pregnant or breast-feeding.
- Participation in a clinical study for acne within 4 months preceding study initiation.
Trial locations and contacts
1 site in 1 country.
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
Acne study
- Conditions
- Acne
- Being tested
- Tretinoin, 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.
TretinoinDrug
Also called active medication
Treatment of acne
placeboDrug
Also called inactive medication
treatment of acne
| Study group | Role | What they receive |
|---|---|---|
| Active generic | Active comparator | Treatment of acne for 12 weeks with generic tretinoin Receives: Drug: Tretinoin |
| Placebo | Placebo comparator | Treatment of acne for 12 weeks with Placebo Receives: Drug: placebo |
| Brand | Active comparator | Treatment of acne over 12 weeks with tretinoin Brand Receives: Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne Lesion Percent Reduction
Reduction in number of Acne lesions by counting over 12 weeks
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 958 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spear Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Cunningham, MD, Study director, Cu-Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243450
- Sponsor's protocol ID
- RAM-04
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2010
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
- ClinicalTrials.gov ID
- NCT01243450
- Acronym / sponsor ID
- RAM-04
- Conditions
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 958 participants (actual)
- Lead sponsor
- Spear PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Posted 18 Nov 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
Acne study
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 |
|---|---|---|
| Active generic | Active comparator | Drug: TretinoinTreatment of acne for 12 weeks with generic tretinoin |
| Placebo | Placebo comparator | Drug: placeboTreatment of acne for 12 weeks with Placebo |
| Brand | Active comparator | Drug: TretinoinTreatment of acne over 12 weeks with tretinoin Brand |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- A subject will be eligible to participate if they meet none of the following exclusion criteria:
- Subjects with active cystic acne as evidenced by more than 2 facial nodules.
- More than 40 papules and/or pustules (inflammatory lesions)
- More than 60 open and or closed comedones/milia (non-inflammatory lesions)
- Overall severity grade of less than 2 or greater than 4,
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 |
|---|---|---|
| TretinoinAlso: active medicationTreatment of acne | Drug | Active generic, Brand |
| placeboAlso: inactive medicationtreatment of acne | Drug | Placebo |
Primary outcome
Acne Lesion Percent Reduction
Time frame: 12 week
Reduction in number of Acne lesions by counting over 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- 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.
William Cunningham, MD study director
Cu-Tech
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 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 0 inclusion and 11 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 3 Jan 2020. 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 18 Nov 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?
Acne Lesion Percent Reduction (time frame: 12 week). 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 3 Jan 2020.