Study to Evaluate the Efficacy and Safety of 1.5 mg/kg/Day of Sarecycline vs Placebo in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

— SC1401  

Official 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02651012
• Other study ID #: SC1401
• Status: Withdrawn
• Phase: Phase 3
• First received: September 18, 2015
• Last updated: December 5, 2016
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Sadick Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A Study to Evaluate the Efficacy and Safety Sarecycline in the Treatment of Acne Vulgaris.

Description:

Treatment of inflammatory lesions of moderate to severe acne vulgaris in subjects 9 to 45 years of age with oral sarecycline 1.5 mg/kg/day compared to placebo in the subjects with moderate to severe facial acne vulgaris based on Investigator's Global Assessment (IGA) score and inflammatory lesion counts. Safety monitored and evaluated throughout 12-week study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 45 Years

Eligibility

Inclusion Criteria:

A subject will be considered for inclusion in the study if he/she meets all of the following criteria:

• Is a male or female, 9 to 45 years of age, inclusive

• Has a body weight between 72 lb and 300 lb, inclusive

• Has facial acne vulgaris with:

• 20 to 50 inflammatory lesions (papules, pustules, and nodules)

• up to 100 noninflammatory lesions (open and closed comedones)

• No more than two nodules

• IGA score of moderate (3) or severe (4)

• Has a negative urine pregnancy test at baseline - females of childbearing potential only

• Agrees to use an effective method of contraception throughout the study, if applicable

• Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for the duration of the study

• Is able to swallow the tablets

Exclusion Criteria:

A subject will be excluded from participation if he/she meets any of the following criteria:

• Has a dermatological condition of the face (e.g., skin burn, sunburn, beard, mustache) 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 randomization:

• Systemic retinoids

• Systemic corticosteroids

• Androgens/anti-androgenic therapy (e.g., anabolic steroids, spironolactone)

• Non-medicated procedures for the treatment of acne

• Has used any acne affecting treatment without an appropriate washout period

• Has initiated hormonal contraceptive use within 12 weeks prior to randomization or plans to initiate or switch hormonal contraceptive products during the study period

• Is pregnant, lactating, or is 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, Cushing's 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 randomization 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• sarecycline
1.5 mg/kg/day sarecycline or placebo tablets for duration of 12 week study
• Placebo
1 tablet taken daily for duration of 12 week study

Locations

Country	Name	City	State
United States	Sadick Research Group	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sadick Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Assessments: Lesion Counts	Lesion count assessed by investigator at screening and baseline as well as all subsequent visits and change rated from baseline results	12 weeks (measured at all site visits)	No
Primary	Efficacy Assessments: Global Physician Acne Rating	global acne ratings assessed by investigator at screening and baseline as well as all subsequent visits and change rated from baseline results.	12 weeks (measured at all site visits)	No
Primary	Efficacy Assessments: Patient Quality of Life Questionnaire	Patient questionnaires assessing acne impact on quality of life will be collected at all visits and change compared from baseline to end of study.	12 weeks (measured at all site visits)	No
Secondary	Safety Assessments: Local Tolerability	Investigator will rate tolerability of treatment at all site visits, comparing back to baseline results. Site staff will collect information regarding adverse events provided by subject at all visits, information will then be reviewed and assessed by investigator.	12 weeks (measured at all site visits)	No
Secondary	Safety Assessments: Adverse Events	Site staff will collect information regarding adverse events provided by subject at all visits, information will then be reviewed and assessed by investigator.	12 weeks (measured at all site visits)	No