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OpenTrials
Completed

NCT Number: NCT02413346

A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris

Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Actavis Investigational Study 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

  • Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402)
  • Signed informed consent or assent form
  • Body weight between 33 kg and 136 kg, inclusive
  • Negative urine pregnancy test for females of childbearing potential
  • Agrees to use effective method of contraception throughout study, if applicable.
  • Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)

Exclusion criteria

  • Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment.
  • Discontinued participation in a Phase 3 study with sarecycline for any reason
  • Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline
  • Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)
  • Is pregnant, lactating or planning a pregnancy during the study period
  • Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
  • Is judged by the Investigator to be unsuitable for any reason

Treatment and study plan

Sarecycline

Drug

Administered based on participant's body weight.

Primary outcomes

  1. Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)

    Time frame: Up to 40 Weeks

    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. A TEAE is an AE that occurs after the first dose of study drug.

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Collaborators

  • Allergan

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 9, 2015
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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