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Status unknownNCT01448733Updated Oct 7, 2011

Safety and Tolerability of Acanya Gel in Combination With Atralin Gel for Acne Vulgaris

A Phase 4 interventional study of Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening in Acne Vulgaris, sponsored by Zeichner, Joshua, M.D.. Status unknown at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2011-10-07.

Sponsored by Zeichner, Joshua, M.D. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • acne vulgaris
03

In context

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's enrollment of 20 is below the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Zeichner, Joshua, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Acanya Plus Atralin

    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.

    Drug: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening

Interventions

  • DrugBenzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening

    Drug page: Benzoyl Peroxide

    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

    Also known as: Acanya Gel, Atralin Gel

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Mt Sinai Hospital, Department of Dermatology
    New York, New York 10029, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2011, a primary completion of Oct 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2011
First posted
Oct 7, 2011
Start
Jul 2011
Primary completionEst.
Oct 2011
CompletionEst.
Oct 2011
Last update
Oct 7, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01448733
Lead sponsor
Zeichner, Joshua, M.D.
Responsible party
Joshua Zeichner (Director of Cosmetic and Clinical Research, Mt Sinai Dermatology, Zeichner, Joshua, M.D.) — Principal investigator
First posted
Oct 7, 2011
Start date
Jul 2011
Primary completion
Oct 2011 (estimated)
Completion
Oct 2011 (estimated)
Last update
Oct 7, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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