Mild to Moderate AcnePhase 4MXMIN-001NCT00988026
Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne
A Phase 4 study testing Minocycline vs Lymecycline in people with Mild to Moderate Acne, run by Darier at 1 site in Mexico.
Trial summary
This is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. It is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Mild to Moderate Acne
- What is being tested?
- Minocycline vs Lymecycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2009to Apr 2010
- 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 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both gender
- 14 to 30 years old
- Mild to moderate acne
- Face localization
- At least 20 non-inflammatory lesions OR
- At least 15 inflammatory lesions OR
- At least 30 total lesions AND
- Less than 5 nodular lesions
Who cannot join
- Patients younger than 14 or older than 30 years old
- Less than 20 non-inflammatory lesions OR
- Less than 15 inflammatory lesions OR
- Less than 30 total lesions
- Patients with severe acne
- More than 5 nodular lesions OR
Show all 10Show fewer
- More than 50 inflammatory lesions OR
- More than 125 total lesions
- Pregnant women
- Lactating women
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
Blanca Ojeda-Martínez, RN, (5281)83481465, blanca_ojeda21@hotmail.com
About this study
Official title: Safety and Efficacy Comparison of Minocycline Microgranules vs Lymecycline in the Treatment of Mild to Moderate Acne. Randomized, Double Blind, Parallel and Prospective Clinical Trial for 8 Weeks
This is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. It is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile.
- Conditions
- Mild to Moderate Acne
- Being tested
- Minocycline vs Lymecycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline vs LymecyclineDrug
Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline 100 mg | Experimental | Minocycline Receives: Drug: Minocycline vs Lymecycline |
| Lymecycline 300 mg | Active comparator | Group B: Lymecycline Receives: Drug: Minocycline vs Lymecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inflammatory and non-inflammatory acne lesions
Measured: 8 weeks
Secondary outcomes (1)
Incidence of local and systemic adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Darier
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988026
- Sponsor's protocol ID
- MXMIN-001
- Acronym
- MXMIN-001
- Status last verified
- Sep 2009
- First submitted
- 30 Sep 2009
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ocampo-Candiani J, Velazquez-Arenas LL, de la Fuente-Garcia A, Trevino-Gomezharper C, Berber A. Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks. J Drugs Dermatol. 2014 Jun;13(6):671-6.
PubMed 24918556
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Comparison of Minocycline Microgranules vs Lymecycline in the Treatment of Mild to Moderate Acne. Randomized, Double Blind, Parallel and Prospective Clinical Trial for 8 Weeks
- ClinicalTrials.gov ID
- NCT00988026
- Acronym / sponsor ID
- MXMIN-001 / MXMIN-001
- Conditions
- Mild to Moderate Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- DarierIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 1 Oct 2009 (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.
This is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. It is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline 100 mg | Experimental | Drug: Minocycline vs LymecyclineMinocycline |
| Lymecycline 300 mg | Active comparator | Drug: Minocycline vs LymecyclineGroup B: Lymecycline |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Both gender
- 14 to 30 years old
- Mild to moderate acne
- Face localization
- At least 20 non-inflammatory lesions OR
Key exclusion criteria (10 listed)
- Patients younger than 14 or older than 30 years old
- Less than 20 non-inflammatory lesions OR
- Less than 15 inflammatory lesions OR
- Less than 30 total lesions
- Patients with severe acne
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 |
|---|---|---|
| Minocycline vs LymecyclineMinocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks. | Drug | Lymecycline 300 mg, Minocycline 100 mg |
Primary outcome
Number of inflammatory and non-inflammatory acne lesions
Time frame: 8 weeks
1 secondary outcome
Incidence of local and systemic adverse events
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
- Derived from this study: PubMed 24918556Ocampo-Candiani J, Velazquez-Arenas LL, de la Fuente-Garcia A, Trevino-Gomezharper C, Berber A. Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks. J Drugs Dermatol. 2014 Jun;13(6):671-6.
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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.
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 vs Lymecycline in people with Mild to Moderate Acne, run by Darier at 1 site in Mexico.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Oct 2009. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Leobardo Velázquez-Arenas, MD ((5281)83481465, leovel2002@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inflammatory and non-inflammatory acne lesions (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00988026, which also lists 1 linked publication.
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 1 Oct 2009.