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Completed

NCT Number: NCT02322866

Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Warner Chilcott Research Site (Site #206), Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Investigator's Global Assessment (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 receive 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.

Treatment and study plan

Sarecycline

Drug

1.5 mg/kg/day taken orally at the same time each day.

Placebo

Drug

Placebo-matching sarecycline tablets, taken orally at the same time each day.

Primary outcomes

  1. Absolute 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 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's Global Assessment (IGA) Scale Success at Week 12

    Time frame: 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. 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.

Secondary outcomes

  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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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 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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (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. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. 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 analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Collaborators

  • Allergan

Registry information

Official study title

A Randomized, Multicenter, Double-blind, Placebo-controlled 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2014
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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