AcnePhase 4NCT00939133
Proof of Concept Study to Investigate the Recurrence of Acne Post Isotretinoin
A Phase 4 study testing tretinoin microsphere 0.04% gel in people with Acne, run by Dermatrials Research at 1 site in Canada.
Trial summary
The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for non-inflammatory papules and comedones to recur. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Acne
- What is being tested?
- tretinoin microsphere 0.04% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Dec 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must fulfill all of the following criteria to be eligible for study admission:
- Males aged between 18 and 45 years old who have successfully completed a treatment of acne with oral isotretinoin (Min 4 months/Maximum 6 months with an average of 5 months and a total of 120-150mg/kg/course).
- Who can attend scheduled study follow-up visits at the outpatient dermatology clinic.
- Agree to informed consent for participation in a study.
- Agree to comply with the treatment and follow up procedures.
Who cannot join
- Patients who receive isotretinoin for condition other than acne vulgaris.
- Patients who have been off isotretinoin for less than 30 days or more than 90 days at the time of enrollment of the study.
- Patients who have used prescription topical acne treatment (tretinoin, benzoyl peroxide, topical antibiotics or any combination products) between the end of therapy of isotretinoin within 2 weeks of study enrollment or oral antibiotics of any type between the end of therapy of isotretinoin within 4 weeks of study enrollment and throughout the study.
- Patients who have been previously diagnosed with an endocrinological disorder likely to cause acne such as genital/adrenal hyperplasia, adrenal tumors or any other hypo androgenetic state.
- Patients who are using any of the systemic medications likely to cause or abate acne such as oral Dilantin or any other epileptic, Finasteride, Spironolactone or Flutamine, testosterone or dietary body-building protein powders.
- Have any nodulo-cystic lesions at baseline.
Show all 18Show fewer
- Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
- Are currently using any medication that in the opinion of the investigator may affect the action or evaluation of the study product or place the subject at undue risk.
- Used abradants, facials, peels containing glycolic or other acids; masks, washes, or soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers; moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids within the past 2 weeks.
- Plan to use medications that are reported to exacerbate acne (e.g., mega-doses of certain vitamins, such as vitamin D [> 2000 IU per day] and vitamin B12 [> 1 mg/day], haloperidol, halogens [e.g., iodide and bromide], lithium, hydantoin, and phenobarbital), because these may impact efficacy assessments. Subjects who plan to use multivitamins, iron supplements and folate are acceptable.
- Had a facial procedure (such as chemical or laser peel, microdermabrasion, blue light treatment, etc) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or if it is planned to be performed during the conduct of the study.
- Have a known hypersensitivity or have had previous allergic reaction to any of the active components or excipients of the study product.
- Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.
- Are currently abusing drugs or alcohol (drug screening not required).
- Have a significant medical history of being immunocompromised.
- Have other conditions that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
- Had any major illness within 30 days before the screening examination.
- Currently are employees of R Vender, an investigator, or contract research organization (CRO) involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blinded Vehicle Controlled Proof of Concept Study to Investigate the Recurrence of Inflammatory and Non-inflammatory Acne Lesions Using Tretinoin Gel (Microsphere) 0.04% in Male Patients Post Oral Isotretinoin Use
The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for non-inflammatory papules and comedones to recur. However, there has been no formal study to look at the prevention of recurrence of these acne lesions post isotretinoin in a long term basis. This may enhance the therapeutic options for post isotretinoin patients in order to prevent recurrence of their disease.
Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.
Read the detailed description
Subjects will be randomized 1:1 to study product or vehicle. Subjects will be randomly assigned to each group by an unblinded dispenser.
The study duration will be 24 weeks with visits at baseline (week 0), week 4, week 8, week 16 and week 24. All study products will be administered once daily for 24 weeks. Subjects will apply a sufficient amount of study product to cover the entire face.
- Conditions
- Acne
- Being tested
- tretinoin microsphere 0.04% gel, vehicle gel
- Keywords
- acne, tretinoin, isotretinoin, recurrence, Retin A micro
- Medical subject headings
- Acne Vulgaris, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tretinoin microsphere 0.04% gelDrug
Also called Retin A micro 0.04%
Applied daily to entire face for six months
vehicle gelDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tretinoin microsphere 0.04% gel | Active comparator | Not described Receives: Drug: tretinoin microsphere 0.04% gel |
| Vehicle gel | Placebo comparator | Not described Receives: Drug: vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objectives-to assess the efficacy of Retin A micro 0.04% on the recurrence rate of acne post isotretinoin use compared to vehicle.
Measured: Six Months
Secondary outcomes (3)
The percent change in lesion counts from baseline to week 16 and 24.
Measured: Six Months
Proportion of subjects who have a Subject's Global
Measured: Assessment score of 0 or 1 at week 16 and 24
Proportion of subjects who have an ISGA score of 0 or 1 at week 16 and 24.
Measured: At week 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatrials Research
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Ronald Vender MD FRCPC, Dermatrials Research
- Investigators
- Ronald Vender, MD FRCPC, Principal investigator, Dermatrials Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939133
- Sponsor's protocol ID
- C2009-01
- Status last verified
- Feb 2015
- First submitted
- 11 Jul 2009
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Vehicle Controlled Proof of Concept Study to Investigate the Recurrence of Inflammatory and Non-inflammatory Acne Lesions Using Tretinoin Gel (Microsphere) 0.04% in Male Patients Post Oral Isotretinoin Use
- ClinicalTrials.gov ID
- NCT00939133
- Acronym / sponsor ID
- C2009-01
- Conditions
- Acne
- Keywords
- acne, tretinoin, isotretinoin, recurrence, Retin A micro
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dermatrials ResearchUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Jul 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.
The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for non-inflammatory papules and comedones to recur. However, there has been no formal study to look at the prevention of recurrence of these acne lesions post isotretinoin in a long term basis. This may enhance the therapeutic options for post isotretinoin patients in order to prevent recurrence of their disease.
Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.
Detailed description
Subjects will be randomized 1:1 to study product or vehicle. Subjects will be randomly assigned to each group by an unblinded dispenser.
The study duration will be 24 weeks with visits at baseline (week 0), week 4, week 8, week 16 and week 24. All study products will be administered once daily for 24 weeks. Subjects will apply a sufficient amount of study product to cover the entire face.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tretinoin microsphere 0.04% gel | Active comparator | Drug: tretinoin microsphere 0.04% gel |
| Vehicle gel | Placebo comparator | Drug: vehicle gel |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males aged between 18 and 45 years old who have successfully completed a treatment of acne with oral isotretinoin (Min 4 months/Maximum 6 months with an average of 5 months and a total of 120-150mg/kg/course).
- Who can attend scheduled study follow-up visits at the outpatient dermatology clinic.
- Agree to informed consent for participation in a study.
- Agree to comply with the treatment and follow up procedures.
Key exclusion criteria (18 listed)
- Patients who receive isotretinoin for condition other than acne vulgaris.
- Patients who have been off isotretinoin for less than 30 days or more than 90 days at the time of enrollment of the study.
- Patients who have used prescription topical acne treatment (tretinoin, benzoyl peroxide, topical antibiotics or any combination products) between the end of therapy of isotretinoin within 2 weeks of study enrollment or oral antibiotics of any type between the end of therapy of isotretinoin within 4 weeks of study enrollment and throughout the study.
- Patients who have been previously diagnosed with an endocrinological disorder likely to cause acne such as genital/adrenal hyperplasia, adrenal tumors or any other hypo androgenetic state.
- Patients who are using any of the systemic medications likely to cause or abate acne such as oral Dilantin or any other epileptic, Finasteride, Spironolactone or Flutamine, testosterone or dietary body-building protein powders.
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 0.04% gelAlso: Retin A micro 0.04%Applied daily to entire face for six months | Drug | Tretinoin microsphere 0.04% gel |
| vehicle gelPlacebo | Drug | Vehicle gel |
Primary outcome
Primary objectives-to assess the efficacy of Retin A micro 0.04% on the recurrence rate of acne post isotretinoin use compared to vehicle.
Time frame: Six Months
3 secondary outcomes
The percent change in lesion counts from baseline to week 16 and 24.
Time frame: Six Months
Proportion of subjects who have a Subject's Global
Time frame: Assessment score of 0 or 1 at week 16 and 24
Proportion of subjects who have an ISGA score of 0 or 1 at week 16 and 24.
Time frame: At week 16 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
Related trials for Acne
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Ronald Vender, MD FRCPC principal investigator
Dermatrials Research
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 tretinoin microsphere 0.04% gel in people with Acne, run by Dermatrials Research 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 5 inclusion and 18 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 10 Feb 2015. 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. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary objectives-to assess the efficacy of Retin A micro 0.04% on the recurrence rate of acne post isotretinoin use compared to vehicle. (time frame: Six Months). 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 10 Feb 2015.