Clinical trial NCT02413346: A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Official title: A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2015-04-09
Enrollment: 490
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 40 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Actavis Investigational Study Site #206
state: Alabama
city: Hot Springs
country: United States
facility: Actavis Investigational Study Site #236
state: Arkansas
city: Carlsbad
country: United States
facility: Actavis Investigational Study Site #245
state: California
city: Encino
country: United States
facility: Actavis Investigational Study Site #129
state: California
city: Fremont
country: United States
facility: Actavis Investigational Study Site #209
state: California
city: Sacramento
country: United States
facility: Actavis Investigational Study Site #147
state: California
city: San Diego
country: United States
facility: Actavis Investigational Study Site #150
state: California
city: San Diego
country: United States
facility: Actavis Investigational Study Site #125
state: California
city: San Diego
country: United States
facility: Actavis Investigational Study Site #204
state: California
city: Denver
country: United States
facility: Actavis Investigational Study Site #222
state: Colorado
city: Wheat Ridge
country: United States
facility: Actavis Investigational Study Site #148
state: Colorado
city: Clearwater
country: United States
facility: Actavis Investigational Study Site #226
state: Florida
city: Jupiter
country: United States
facility: Actavis Investigational Study Site #238
state: Florida
city: Miami
country: United States
facility: Actavis Investigational Study Site #249
state: Florida
city: Miami
country: United States
facility: Actavis Investigational Study Site #145
state: Florida
city: Miramar
country: United States
facility: Actavis Investigational Study Site #211
state: Florida
city: North Miami Beach
country: United States
facility: Actavis Investigation Study Site # 140
state: Florida
city: Orange
country: United States
facility: Actavis Investigational Study Site #151
state: Florida
city: Tampa
country: United States
facility: Actavis Investigational Study Site #203
state: Florida
city: Snellville
country: United States
facility: Actavis Investigational Study Site #242
state: Georgia
city: Boise
country: United States
facility: Actavis Investigational Study Site #124
state: Idaho
city: Chicago
country: United States
facility: Actavis Investigational Study Site #106
state: Illinois
city: South Bend
country: United States
facility: Actavis Investigational Study Site #113
state: Indiana
city: Louisville
country: United States
facility: Actavis Investigational Study Site #213
state: Kentucky
city: Rockville
country: United States
facility: Actavis Investigational Study Site #217
state: Maryland
city: Clarkston
country: United States
facility: Actavis Investigational Study Site #251
state: Michigan
city: Clinton Township
country: United States
facility: Actavis Investigational Study Site #235
state: Michigan
city: Fort Gratiot
country: United States
facility: Actavis Investigational Study Site #227
state: Michigan
city: Warren
country: United States
facility: Actavis Investigational Study Site #111
state: Michigan
city: Fridley
country: United States
facility: Actavis Investigational Study Site #221
state: Minnesota
city: Omaha
country: United States
facility: Actavis Investigational Study Site #231
state: Nebraska
city: New York
country: United States
facility: Actavis Investigational Study Site #146
state: New York
city: New York
country: United States
facility: Actavis Investigational Study Site #208
state: New York
city: Rochester
country: United States
facility: Actavis Investigational Study Site #240
state: New York
city: Stony Brook
country: United States
facility: Actavis Investigational Study Site #230
state: New York
city: Raleigh
country: United States
facility: Actavis Investigational Study Site #229
state: North Carolina
city: Gresham
country: United States
facility: Actavis Investigational Study Site #149
state: Oregon
city: Philadelphia
country: United States
facility: Actavis Investigational Study Site #257
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Actavis Investigational Study Site #225
state: Tennessee
city: Knoxville
country: United States
facility: Actavis Investigational Study Site #128
state: Tennessee
city: Knoxville
country: United States
facility: Actavis Investigational Study Site #216
state: Tennessee
city: Nashville
country: United States
facility: Actavis Investigational Study Site #109
state: Tennessee
city: Arlington
country: United States
facility: Actavis Investigational Study Site #223
state: Texas
city: Arlington
country: United States
facility: Actavis Investigational Study Site #252
state: Texas
city: College Station
country: United States
facility: Actavis Investigational Study Site #220
state: Texas
city: Dallas
country: United States
facility: Actavis Investigational Study Site #104
state: Texas
city: Houston
country: United States
facility: Actavis Investigational Study Site #142
state: Texas
city: Houston
country: United States
facility: Actavis Investigational Study Site #105
state: Texas
city: Katy
country: United States
facility: Actavis Investigational Study Site #201
state: Texas
city: Pflugerville
country: United States
facility: Actavis Investigational Study Site #223
state: Texas
city: Plano
country: United States
facility: Actavis Investigational Study Site #101
state: Texas
city: San Antonio
country: United States
facility: Actavis Investigational Study Site #207
state: Texas
city: West Jordan
country: United States
facility: Actavis Investigational Study Site #212
state: Utah
city: Norfolk
country: United States
facility: Actavis Investigational Study Site #244
state: Virginia
city: Spokane
country: United States
facility: Actavis Investigational Study Site #144
state: Washington
city: Walla Walla
country: United States
facility: Actavis Investigational Study Site #233
state: Washington
Study officials:
affiliation: Allergan, plc
name: David Berk, MD
role: STUDY_DIRECTOR
References:
citation: Pariser DM, Green LJ, Lain EL, Schmitz C, Chinigo AS, McNamee B, Berk DR. Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: Results from a Phase III, Multicenter, Open-Label Study and a Phase I Phototoxicity Study. J Clin Aesthet Dermatol. 2019 Nov;12(11):E53-E62. Epub 2019 Nov 1.