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Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02320149
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : May 17, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Brief Summary:
To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Sarecycline Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 968 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris
Actual Study Start Date : December 18, 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Sarecycline
Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
Drug: Sarecycline
1.5 mg/kg/day taken orally at the same time each day,

Placebo Comparator: Placebo
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Drug: Placebo
Placebo-matching sarecycline tablets taken orally at the same time each day.




Primary Outcome Measures :
  1. Absolute Change in Facial Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  2. Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
    The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  2. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  3. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Week 6 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  4. Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  5. Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  6. Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Weeks 6 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  7. Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  8. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  9. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  10. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Week 6 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  11. Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  12. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  13. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 [ Time Frame: Baseline (Day 1) to Week 9 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  14. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 [ Time Frame: Baseline (Day 1) to Week 6 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

  15. Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 [ Time Frame: Baseline (Day 1) to Week 3 ]
    Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent or assent form
  • Male/female, 9 to 45 years of age, inclusive
  • Body weight between 33 and 136 kg, inclusive
  • Facial acne vulgaris with:
  • 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones)
  • No more than 2 nodules
  • IGA score of moderate (3) or severe (4)
  • Negative urine pregnancy test at baseline - females of childbearing potential
  • Agrees to use an effective method of contraception throughout the study
  • Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
  • Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI)

Exclusion Criteria:

  • Has a dermatological condition of the face that could interfere with the clinical evaluations
  • Has a history of any of the following:
  • Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
  • Pseudomembranous colitis or antibiotic associated colitis
  • Treated for any type of cancer within the last 6 months
  • Has known resistance to other tetracyclines
  • Has received any of the following treatments within 12 weeks of screening:
  • Systemic retinoids
  • Systemic corticosteroids
  • Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
  • Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
  • Has used any acne affecting treatment without an appropriate washout period
  • Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
  • Is pregnant, lactating or planning a pregnancy during the study period
  • Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia
  • Has drug-induced acne
  • Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
  • Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study
  • Has previously participated in any clinical trial involving the use of sarecycline
  • Is judged by the Investigator to be unsuitable for any reason

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): NCT02320149


  Hide Study Locations
Locations
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United States, California
Warner Chilcott Research Site (Site #155)
Beverly Hills, California, United States, 90210
Warner Chilcott Research Site (Site #129)
Encino, California, United States, 91436
Warner Chilcott Research Site (Site #150)
La Mesa, California, United States, 91942
Warner Chilcott Research Site (Site #136)
Los Angeles, California, United States, 90045
Warner Chilcott Research Site (Site #147)
Sacramento, California, United States, 95819
Warner Chilcott Research Site (Site #123)
San Diego, California, United States, 92117
Warner Chilcott Research Site (Site #125)
San Diego, California, United States, 92123
Warner Chilcott Research Site (Site #139)
Santa Rosa, California, United States, 95403
Warner Chilcott Research Site (Site #157)
Tustin, California, United States, 92780
United States, Colorado
Warner Chilcott Research Site (Site #122)
Denver, Colorado, United States, 80209
Warner Chilcott Research Site (Site #148)
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Warner Chilcott Research Site (Site #133)
New Haven, Connecticut, United States, 06511
United States, Florida
Warner Chilcott Research Site (Site #130)
Boca Raton, Florida, United States, 33486
Warner Chilcott Research Site (Site #152)
Boynton Beach, Florida, United States, 33437
Warner Chilcott Research Site (Site #102)
Miami, Florida, United States, 33025
Warner Chilcott Research Site (Site #145)
Miami, Florida, United States, 33175
Warner Chilcott Research Site (Site #140)
North Miami Beach, Florida, United States, 33162
Warner Chilcott Research Site (Site #151)
Orange Park, Florida, United States, 32073
Warner Chilcott Research Site (Site #108)
Sanford, Florida, United States, 32771
Warner Chilcott Research Site (Site #110)
West Palm Beach, Florida, United States, 33409
United States, Georgia
Warner Chilcott Research Site (Site #154)
Atlanta, Georgia, United States, 30328
Warner Chilcott Research Site (Site #120)
Augusta, Georgia, United States, 30909
United States, Idaho
Warner Chilcott Research Site (Site #124)
Boise, Idaho, United States, 83704
United States, Illinois
Warner Chilcott Research Site (Site #106)
Chicago, Illinois, United States, 60611
United States, Indiana
Warner Chilcott Research Site (Site #112)
Plainfield, Indiana, United States, 46168
Warner Chilcott Research Site (Site #113)
South Bend, Indiana, United States, 46617
United States, Kentucky
Warner Chilcott Research Site (Site #117)
Louisville, Kentucky, United States, 40217
United States, Louisiana
Warner Chilcott Research Site (Site #135)
Lake Charles, Louisiana, United States, 70605
Warner Chilcott Research Site (Site #153)
Metairie, Louisiana, United States, 70006
United States, Michigan
Warner Chilcott Research Site (Site #137)
Detroit, Michigan, United States, 48202
Warner Chilcott Research Site (Site #111)
Warren, Michigan, United States, 48088
United States, Missouri
Warner Chilcott Research Site (Site #119)
Saint Louis, Missouri, United States, 63117
United States, Nebraska
Warner Chilcott Research Site (Site #138)
Omaha, Nebraska, United States, 68114
United States, Nevada
Warner Chilcott Research Site (Site #103)
Henderson, Nevada, United States, 89074
United States, New Jersey
Warner Chilcott Research Site (Site #127)
Verona, New Jersey, United States, 07044
United States, New York
Warner Chilcott Research Site (Site #146)
New York, New York, United States, 10016
Warner Chilcott Research Site (Site #132)
New York, New York, United States, 10075
Warner Chilcott Research Site (Site #134)
Smithtown, New York, United States, 11787
United States, North Carolina
Warner Chilcott Research Site (Site #107)
High Point, North Carolina, United States, 27262
United States, Ohio
Warner Chilcott Research Site (Site #126)
Cincinnati, Ohio, United States, 45249
Warner Chilcott Research Site (Site #143)
Warren, Ohio, United States, 44483
United States, Oregon
Warner Chilcott Research Site (Site #149)
Gresham, Oregon, United States, 97030
Warner Chilcott Research Site (Site #131)
Portland, Oregon, United States, 97210
United States, South Carolina
Warner Chilcott Research Site (Site #114)
Greer, South Carolina, United States, 29650
United States, Tennessee
Warner Chilcott Research Site (Site #128)
Knoxville, Tennessee, United States, 37917
Warner Chilcott Research Site (Site #109)
Nashville, Tennessee, United States, 37215
United States, Texas
Warner Chilcott Research Site (Site #116)
Austin, Texas, United States, 78759
Warner Chilcott Research Site (Site #104)
Dallas, Texas, United States, 75234
Warner Chilcott Research Site (Site #115)
El Paso, Texas, United States, 79902
Warner Chilcott Research Site (Site #142)
Houston, Texas, United States, 77004
Warner Chilcott Research Site (Site #105)
Houston, Texas, United States, 77056
Warner Chilcott Research Site (Site #101)
Plano, Texas, United States, 75093
Warner Chilcott Research Site (Site #118)
San Antonio, Texas, United States, 78229
United States, Utah
Warner Chilcott Research Site (Site #156)
Layton, Utah, United States, 84041
Warner Chilcott Research Site (Site #141)
Salt Lake City, Utah, United States, 84117
United States, Virginia
Warner Chilcott Research Site (Site #121)
Charlottesville, Virginia, United States, 22911
United States, Washington
Warner Chilcott Research Site (Site #144)
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Almirall, S.A.
Allergan
Investigators
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Study Director: Alexandre Kaoukhov, MD Warner Chilcott, an Affiliate of Allergan plc
  Study Documents (Full-Text)

Documents provided by Almirall, S.A.:
Study Protocol  [PDF] December 16, 2015
Statistical Analysis Plan  [PDF] March 3, 2017


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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02320149     History of Changes
Obsolete Identifiers: NCT02651012
Other Study ID Numbers: SC1401
First Posted: December 19, 2014    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: February 15, 2019
Last Verified: January 2019
Keywords provided by Almirall, S.A.:
acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Sarecycline
Anti-Bacterial Agents
Anti-Infective Agents
Dermatologic Agents