Acne VulgarisPhase 4NCT00240513
Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin
A Phase 4 study testing Minocycline and Minocycline plus tretinoin in people with Acne Vulgaris, run by Derm Research @ 888 Inc. at 1 site in Canada.
Trial summary
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit. Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Minocycline and Minocycline plus tretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2004to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provision of written consent
- Either sex
- Any age
- Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face.
Who cannot join
- Known hypersensitivity to tetracyclines
- Use of any oral antibiotics in the previous 3 months
- Pregnancy, breast-feeding or lactating
- Inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator.
- Concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes.
- Patients with severe acne on the chest, back or trunk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Compare the Acne Relapse Rate After a 3-mo Course of Oral Minocycline, to a 3-mo Course of Oral Minocycline in Combination With a Daily Dose of Topical Tretinoin 0.01% Followed by 3 mo of Topical Tretinoin Alone
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.
Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.
Read the detailed description
Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.
Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.
The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.
- Conditions
- Acne Vulgaris
- Being tested
- Minocycline, Minocycline plus tretinoin
- Keywords
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Minocin
100 mg capsules OD for 3 months
Minocycline plus tretinoinDrug
Also called Minocin, Tretinoin
100mg OD Minocycline for 12 weeks plus OD Topical tretinoin 0.01% for 12 weeks Followed by topical tretinoin 0.01% OD for 12 weeks alone
| Study group | Role | What they receive |
|---|---|---|
| Minocycline 3 mo | Active comparator | Minocycline 3 mo Receives: Drug: Minocycline |
| Minocycline plus Tretinoin | Experimental | Minocycline plus Tretinoin for 3 months Receives: Drug: Minocycline plus tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term efficacy
Measured: 4 years
Secondary outcomes (1)
Relapse rate
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Too much difficulty recruiting and retaining patients, PI decided to stop.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derm Research @ 888 Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stiefel, a GSK Company
- Responsible party
- Principal investigator, David Richard THOMAS, Derm Research @ 888 Inc.
- Investigators
- Richard Thomas, MD, FRCP(C), Principal investigator, DermResearch @ 888 Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240513
- Sponsor's protocol ID
- 2004-03
- Status last verified
- Feb 2012
- First submitted
- 16 Oct 2005
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare the Acne Relapse Rate After a 3-mo Course of Oral Minocycline, to a 3-mo Course of Oral Minocycline in Combination With a Daily Dose of Topical Tretinoin 0.01% Followed by 3 mo of Topical Tretinoin Alone
- ClinicalTrials.gov ID
- NCT00240513
- Acronym / sponsor ID
- 2004-03
- Conditions
- Acne Vulgaris
- Keywords
- Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too much difficulty recruiting and retaining patients, PI decided to stop.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Derm Research @ 888 Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stiefel, a GSK Company
- Study start
- Aug 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.
Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.
Detailed description
Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.
Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.
The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline 3 mo | Active comparator | Drug: MinocyclineMinocycline 3 mo |
| Minocycline plus Tretinoin | Experimental | Drug: Minocycline plus tretinoinMinocycline plus Tretinoin for 3 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of written consent
- Either sex
- Any age
- Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face.
Key exclusion criteria (6 listed)
- Known hypersensitivity to tetracyclines
- Use of any oral antibiotics in the previous 3 months
- Pregnancy, breast-feeding or lactating
- Inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator.
- Concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes.
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 |
|---|---|---|
| MinocyclineAlso: Minocin100 mg capsules OD for 3 months | Drug | Minocycline 3 mo |
| Minocycline plus tretinoinAlso: Minocin, Tretinoin100mg OD Minocycline for 12 weeks plus OD Topical tretinoin 0.01% for 12 weeks Followed by topical tretinoin 0.01% OD for 12 weeks alone | Drug | Minocycline plus Tretinoin |
Primary outcome
Long-term efficacy
Time frame: 4 years
1 secondary outcome
Relapse rate
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Too much difficulty recruiting and retaining patients, PI decided to stop.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
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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.
Richard Thomas, MD, FRCP(C) principal investigator
DermResearch @ 888 Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline and Minocycline plus tretinoin in people with Acne Vulgaris, run by Derm Research @ 888 Inc. at 1 site in Canada.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Feb 2012. 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 Canada. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Too much difficulty recruiting and retaining patients, PI decided to stop.). Results are not available in the source record.
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?
Long-term efficacy (time frame: 4 years). 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 24 Feb 2012.