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

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening
Sponsored by
Zeichner, Joshua, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Mt Sinai Hospital, Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acanya Plus Atralin

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 5, 2011
Last Updated
October 6, 2011
Sponsor
Zeichner, Joshua, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01448733
Brief Title
Safety and Tolerability of Acanya Gel in Combination With Atralin Gel for Acne Vulgaris
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeichner, Joshua, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acanya Plus Atralin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening
Other Intervention Name(s)
Acanya Gel, Atralin Gel
Intervention Description
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
Primary Outcome Measure Information:
Title
Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
Description
Evaluation of skin erythema, scaling, drying, and stinging/burning
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
Description
Evaluation of efficacy as defined as a global assessment of clear or almost clear after 12 weeks of therapy.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Facility Information:
Facility Name
Mt Sinai Hospital, Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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