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

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ClinicalTrials.gov Identifier: NCT02413346
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 490 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Actual Study Start Date : March 20, 2015
Actual Primary Completion Date : August 26, 2016
Actual Study Completion Date : August 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Placebo/Sarecycline
Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
Drug: Sarecycline
Administered based on participant's body weight.

Experimental: Sarecycline/Sarecycline
Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
Drug: Sarecycline
Administered based on participant's body weight.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02413346


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Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: David Berk, MD Allergan plc

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT02413346     History of Changes
Other Study ID Numbers: SC1403
First Posted: April 9, 2015    Key Record Dates
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018
Last Verified: April 2018

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