Acne VulgarisPhase 4NCT01422785
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
A Phase 4 study testing clindamycin phosphate 1.2%/tretinoin 0.025% gel alone and clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths in people with Acne Vulgaris, run by Zeichner, Joshua, M.D. at 1 site in United States.
Trial summary
There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- clindamycin phosphate 1.2%/tretinoin 0.025% gel alone and clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2011
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ≥ 12 years old.
- Subjects must be in good general health as confirmed by medical history and physical examination.
- Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
- Clear diagnosis of facial acne vulgaris for at least 3 months.
- Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
- Disease must be stable or slowly worsening for more than one week prior to entering the study.
- Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.
Who cannot join
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to study drug.
- Subjects with very severe acne (PGA score of 5)
- Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
- Subjects with a current active skin malignancy or infection.
- Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
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- Subjects who have received systemic antibiotics within 2 weeks.
- Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
- Subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study.
- Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
- Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
- Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Trial locations and contacts
1 site in 1 country.
Vicky Wong contact
United States1 site, 1 recruiting
- Recruiting
Mt Sinai Hospital - Dept of Dermatology
New York, New York, 10029
Vicky Wong, 212-241-3288
Joshua Zeichner, MD
About this study
Official title: A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment of Facial Acne Vulgaris
There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.
- Conditions
- Acne Vulgaris
- Being tested
- clindamycin phosphate 1.2%/tretinoin 0.025% gel alone, clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths
- Keywords
- Acne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clindamycin phosphate 1.2%/tretinoin 0.025% gel aloneDrug
Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming clothsDrug
wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.
| Study group | Role | What they receive |
|---|---|---|
| clindamycin phosphate 1.2%/tretinoin 0.025% gel alone | Active comparator | Not described Receives: Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone |
| clindamycin / tretinoin gel plus benzoyl peroxide | Active comparator | Not described Receives: Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.
Measured: Weeks 2, 4, 8, 12
Secondary outcomes (4)
Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.
Change in PIH score from baseline will be assessed. (based on a 6 point scale)
Measured: Weeks 2, 4, 8, 12
Total number of adverse events.
Safety/drug-tolerance evaluated at each visit (total number of adverse events)
Measured: Weeks 2, 4, 8, 12
Change in Subject Self Assessment Scoring Scale
Patient rates current severity of their acne.
Measured: Weeks 2, 4, 8, 12
Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
Acne-QoL as completed by patient.
Measured: Weeks 2, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeichner, Joshua, M.D.
- Responsible party
- Principal investigator, Joshua Zeichner, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422785
- Sponsor's protocol ID
- GCO 10-1602
- Status last verified
- Aug 2011
- First submitted
- 12 Aug 2011
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment of Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01422785
- Acronym / sponsor ID
- GCO 10-1602
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zeichner, Joshua, M.D.
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- First posted
- 24 Aug 2011 (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.
There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clindamycin phosphate 1.2%/tretinoin 0.025% gel alone | Active comparator | Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone |
| clindamycin / tretinoin gel plus benzoyl peroxide | Active comparator | Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥ 12 years old.
- Subjects must be in good general health as confirmed by medical history and physical examination.
- Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
- Clear diagnosis of facial acne vulgaris for at least 3 months.
- Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
Key exclusion criteria (12 listed)
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to study drug.
- Subjects with very severe acne (PGA score of 5)
- Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
- Subjects with a current active skin malignancy or infection.
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 |
|---|---|---|
| clindamycin phosphate 1.2%/tretinoin 0.025% gel aloneOnce daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening | Drug | clindamycin phosphate 1.2%/tretinoin 0.025% gel alone |
| clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming clothswash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening. | Drug | clindamycin / tretinoin gel plus benzoyl peroxide |
Primary outcome
Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
Time frame: Weeks 2, 4, 8, 12
The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.
4 secondary outcomes
Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.
Time frame: Weeks 2, 4, 8, 12
Total number of adverse events.
Time frame: Weeks 2, 4, 8, 12
Change in Subject Self Assessment Scoring Scale
Time frame: Weeks 2, 4, 8, 12
Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
Time frame: Weeks 2, 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
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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.
Vicky Wong contact
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 clindamycin phosphate 1.2%/tretinoin 0.025% gel alone and clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths in people with Acne Vulgaris, run by Zeichner, Joshua, M.D. 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 7 inclusion and 12 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 24 Aug 2011. 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. 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 Vicky Wong (212-241-3288), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne (time frame: Weeks 2, 4, 8, 12). 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 Aug 2011.