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

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ClinicalTrials.gov Identifier: NCT02320149
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

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

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.


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


  Show 57 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Alexandre Kaoukhov, MD Warner Chilcott, an Affiliate of Allergan plc
  Study Documents (Full-Text)

Documents provided by Warner Chilcott:
Study Protocol  [PDF] December 16, 2015
Statistical Analysis Plan  [PDF] March 3, 2017


Responsible Party: Warner Chilcott
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: May 17, 2018
Last Verified: April 2018

Keywords provided by Warner Chilcott:
acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases