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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Zeichner, Joshua, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Joshua Zeichner, Zeichner, Joshua, M.D.
ClinicalTrials.gov Identifier:
NCT01448733
First received: October 5, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Zeichner, Joshua, M.D.:

Primary Outcome Measures:
  • Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of efficacy as defined as a global assessment of clear or almost clear after 12 weeks of therapy.


Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Names:
  • Acanya Gel
  • Atralin Gel

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448733

Locations
United States, New York
Mt Sinai Hospital, Department of Dermatology
New York, New York, United States, 10029
Sponsors and Collaborators
Zeichner, Joshua, M.D.
  More Information

No publications provided

Responsible Party: Joshua Zeichner, Director of Cosmetic and Clinical Research, Mt Sinai Dermatology, Zeichner, Joshua, M.D.
ClinicalTrials.gov Identifier: NCT01448733     History of Changes
Other Study ID Numbers: Coria Combo
Study First Received: October 5, 2011
Last Updated: October 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Zeichner, Joshua, M.D.:
acne vulgaris

Additional relevant MeSH terms:
Tretinoin
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2014