Acne VulgarisPhase 4NCT01448733
Safety and Tolerability of Acanya Gel in Combination With Atralin Gel for Acne Vulgaris
A Phase 4 study testing Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening in people with Acne Vulgaris, run by Zeichner, Joshua, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and effective for the treatment of acne vulgaris. 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?
- Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 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 be abstinent or use adequate birth control during the study (oral contraceptives, Norplant, Depo-Provera, or double barrier methods (e.g., condom and spermicide).
- Clear diagnosis of facial acne vulgaris for at least 6 months.
- Subject must have a static Physician's Global Assessment (PGA) of 2 (mild severity) or 3 (moderate severity).
- 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 any ingredients in the study drugs.
- 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.
- Subjects who have received systemic antibiotics within 2 weeks.
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- Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
- Subjects who have received any topical therapies for acne vulgaris within 7 days of entering the study.
- Subjects taking birth control pills used solely for acne control.
- 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.
- Subjects who have Crohn's disease, colitis, or if subjects ever developed colitis or severe diarrhea with past antibiotic use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mt Sinai Hospital, Department of Dermatology
New York, New York, 10029
About this study
Official title: A Pilot Study to Evaluate the Safety and Tolerability of CeraVe® Lotion Followed by Fixed Dose Clindamycin Phosphate 1.2% / Benzoyl Peroxide 2.5% Gel in the Morning in Combination With CeraVe® Lotion Followed by Tretinoin 0.05% Gel in the Evening for the Treatment of Facial Acne Vulgaris.
The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and effective for the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening
- 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.
Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the eveningDrug
Also called Acanya Gel, Atralin Gel
Green pea sized amount of Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning in combination with a green pea sized amount of tretinoin 0.05% gel in the evening
| Study group | Role | What they receive |
|---|---|---|
| Acanya Plus Atralin | Experimental | A single, open-label arm treating acne with Cerave lotion plus Acanya gel in the morning in combination with Cerave lotion plus Atralin gel in the evening. Receives: Drug: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
Evaluation of skin erythema, scaling, drying, and stinging/burning
Measured: 12 weeks
Secondary outcomes (1)
Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
Evaluation of efficacy as defined as a global assessment of clear or almost clear after 12 weeks of therapy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011 (estimated)
- Study completionOct 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeichner, Joshua, M.D.
- Responsible party
- Principal investigator, Joshua Zeichner, Zeichner, Joshua, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448733
- Sponsor's protocol ID
- Coria Combo
- Status last verified
- Oct 2011
- First submitted
- 5 Oct 2011
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Tolerability of CeraVe® Lotion Followed by Fixed Dose Clindamycin Phosphate 1.2% / Benzoyl Peroxide 2.5% Gel in the Morning in Combination With CeraVe® Lotion Followed by Tretinoin 0.05% Gel in the Evening for the Treatment of Facial Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT01448733
- Acronym / sponsor ID
- Coria Combo
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zeichner, Joshua, M.D.
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 7 Oct 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.
The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and effective for the treatment of acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acanya Plus Atralin | Experimental | Drug: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the eveningA single, open-label arm treating acne with Cerave lotion plus Acanya gel in the morning in combination with Cerave lotion plus Atralin gel in the evening. |
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 be abstinent or use adequate birth control during the study (oral contraceptives, Norplant, Depo-Provera, or double barrier methods (e.g., condom and spermicide).
- Clear diagnosis of facial acne vulgaris for at least 6 months.
- Subject must have a static Physician's Global Assessment (PGA) of 2 (mild severity) or 3 (moderate severity).
Key exclusion criteria (12 listed)
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to any ingredients in the study drugs.
- 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.
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 |
|---|---|---|
| Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the eveningAlso: Acanya Gel, Atralin GelGreen pea sized amount of Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning in combination with a green pea sized amount of tretinoin 0.05% gel in the evening | Drug | Acanya Plus Atralin |
Primary outcome
Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
Time frame: 12 weeks
Evaluation of skin erythema, scaling, drying, and stinging/burning
1 secondary outcome
Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening 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 7 Oct 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?
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?
Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris (time frame: 12 weeks). 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 7 Oct 2011.