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A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne

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ClinicalTrials.gov Identifier: NCT01422785
Recruitment Status : Unknown
Verified August 2011 by Joshua Zeichner, Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Recruiting
First Posted : August 24, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Joshua Zeichner, Icahn School of Medicine at Mount Sinai

Brief 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. This study will evaluate the use of the medications when used together.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2011
Estimated Primary Completion Date : December 2011


Arm Intervention/treatment
Active Comparator: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening

Active Comparator: clindamycin / tretinoin gel plus benzoyl peroxide Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit. [ Time Frame: Weeks 2, 4, 8, 12 ]
    Change in PIH score from baseline will be assessed. (based on a 6 point scale)

  2. Total number of adverse events. [ Time Frame: Weeks 2, 4, 8, 12 ]
    Safety/drug-tolerance evaluated at each visit (total number of adverse events)

  3. Change in Subject Self Assessment Scoring Scale [ Time Frame: Weeks 2, 4, 8, 12 ]
    Patient rates current severity of their acne.

  4. Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL) [ Time Frame: Weeks 2, 4, 8, 12 ]
    Acne-QoL as completed by patient.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422785


Contacts
Contact: Vicky Wong 212-241-3288

Locations
United States, New York
Mt Sinai Hospital - Dept of Dermatology Recruiting
New York, New York, United States, 10029
Contact: Vicky Wong    212-241-3288      
Principal Investigator: Joshua Zeichner, MD         
Sponsors and Collaborators
Zeichner, Joshua, M.D.

Responsible Party: Joshua Zeichner, Zeichner, Joshua, M.D., Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01422785     History of Changes
Other Study ID Numbers: GCO 10-1602
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by Joshua Zeichner, Icahn School of Medicine at Mount Sinai:
Acne Vulgaris

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