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

A Phase 3 study testing Sarecycline in people with Acne Vulgaris, run by Almirall, S.A. at 56 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Sarecycline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 490 participants
Where: 56 sitesUnited States
Study dates: 20 Mar 2015to 26 Aug 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

56 sites in 1 country.

City, postcode or hospital

56 sites in 1 country

United States56 sites

Actavis Investigational Study Site #223
Arlington, Texas, 76011
Actavis Investigational Study Site #252
Arlington, Texas, 76011
Actavis Investigational Study Site #124
Boise, Idaho, 83704
Actavis Investigational Study Site #245
Carlsbad, California, 92008
Actavis Investigational Study Site #106
Chicago, Illinois, 60611
Actavis Investigational Study Site #251
Clarkston, Michigan, 48346
Actavis Investigational Study Site #226
Clearwater, Florida, 33761
Actavis Investigational Study Site #235
Clinton Township, Michigan, 48038
Actavis Investigational Study Site #220
College Station, Texas, 77845
Actavis Investigational Study Site #104
Dallas, Texas, 75234
Actavis Investigational Study Site #222
Denver, Colorado, 80220
Actavis Investigational Study Site #129
Encino, California, 91436
Actavis Investigational Study Site #227
Fort Gratiot, Michigan, 48059
Actavis Investigational Study Site #209
Fremont, California, 94538
Actavis Investigational Study Site #221
Fridley, Minnesota, 55432
Actavis Investigational Study Site #225
Goodlettsville, Tennessee, 37072
Actavis Investigational Study Site #149
Gresham, Oregon, 97030
Actavis Investigational Study Site #236
Hot Springs, Arkansas, 71913
Actavis Investigational Study Site #142
Houston, Texas, 77004
Actavis Investigational Study Site #105
Houston, Texas, 77056
Actavis Investigational Study Site #238
Jupiter, Florida, 33458
Actavis Investigational Study Site #201
Katy, Texas, 77494
Actavis Investigational Study Site #128
Knoxville, Tennessee, 37917
Actavis Investigational Study Site #216
Knoxville, Tennessee, 37922
Actavis Investigational Study Site #213
Louisville, Kentucky, 40202
Actavis Investigational Study Site #249
Miami, Florida, 33142
Actavis Investigational Study Site #145
Miami, Florida, 33175
Actavis Investigational Study Site #211
Miramar, Florida, 33207
Actavis Investigational Study Site #206
Mobile, Alabama, 36608
Actavis Investigational Study Site #109
Nashville, Tennessee, 37215
Actavis Investigational Study Site #146
New York, New York, 10016
Actavis Investigational Study Site #208
New York, New York, 10155
Actavis Investigational Study Site #244
Norfolk, Virginia, 23507
Actavis Investigation Study Site # 140
North Miami Beach, Florida, 33162
Actavis Investigational Study Site #231
Omaha, Nebraska, 68144
Actavis Investigational Study Site #151
Orange, Florida, 32073
Actavis Investigational Study Site #223
Pflugerville, Texas, 78660
Actavis Investigational Study Site #257
Philadelphia, Pennsylvania, 19103
Actavis Investigational Study Site #101
Plano, Texas, 75093
Actavis Investigational Study Site #229
Raleigh, North Carolina, 27612
Actavis Investigational Study Site #240
Rochester, New York, 14623
Actavis Investigational Study Site #217
Rockville, Maryland, 20850
Actavis Investigational Study Site #147
Sacramento, California, 95819
Actavis Investigational Study Site #207
San Antonio, Texas, 78218
Actavis Investigational Study Site #150
San Diego, California, 92120
Actavis Investigational Study Site #125
San Diego, California, 92123
Actavis Investigational Study Site #204
San Diego, California, 92123
Actavis Investigational Study Site #242
Snellville, Georgia, 30078
Actavis Investigational Study Site #113
South Bend, Indiana, 46617
Actavis Investigational Study Site #144
Spokane, Washington, 99202
Actavis Investigational Study Site #230
Stony Brook, New York, 11790
Actavis Investigational Study Site #203
Tampa, Florida, 33609
Actavis Investigational Study Site #233
Walla Walla, Washington, 99362
Actavis Investigational Study Site #111
Warren, Michigan, 48088
Actavis Investigational Study Site #212
West Jordan, Utah, 84088
Actavis Investigational Study Site #148
Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

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.

Conditions: Acne Vulgaris
Being tested: Sarecycline
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SarecyclineDrug
Administered based on participant's body weight.

Study groups in NCT02413346
Study group	Role	What they receive
Placebo/Sarecycline	Experimental	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). Receives: Drug: Sarecycline
Sarecycline/Sarecycline	Experimental	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). Receives: Drug: Sarecycline

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
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.
Measured: Up to 40 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201526 Aug 2016

First posted9 Apr 2015 (estimated)
Study start20 Mar 2015
Primary completion26 Aug 2016
Study completion26 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
More trials run by Almirall, S.A.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 490 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02413346
Sponsor's protocol ID: SC1403
Status last verified: Jan 2019
First submitted: 2 Apr 2015
Last updated: 1 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 32038757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT02413346
Acronym / sponsor ID: SC1403
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 490 participants (actual)
Lead sponsor: Almirall, S.A.Industry (pharma, biotech, devices)
Collaborators: Allergan
Study start: 20 Mar 2015 (actual)
Primary completion: 26 Aug 2016 (actual)
Study completion: 26 Aug 2016 (actual)
First posted: 9 Apr 2015 (estimated)
Results: Posted 4 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Placebo/Sarecycline	Experimental	Drug: SarecyclineParticipants 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).
Sarecycline/Sarecycline	Experimental	Drug: SarecyclineParticipants 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).

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SarecyclineAdministered based on participant's body weight.	Drug	Placebo/Sarecycline, Sarecycline/Sarecycline

Primary outcome

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.

Results and safety

Results posted to the registry on 4 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Sarecycline	236	177
Sarecycline/Sarecycline	247	177

Primary outcome: Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)

Time frame: Up to 40 Weeks. Number. Unit: participants

Measure	Placebo/Sarecycline n = 236	Sarecycline/Sarecycline n = 247
Value	94	94

Population analysed: Safety Population included all participants among the screened population who were exposed to study treatment (sarecycline) in either the double-blind lead-in study or this open-label extension study.

Adverse events

Time frame: Signing of informed consent for this open-label study to end of study (Up to 40 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/Sarecycline	2 of 236 (0.8%)	13 of 236 (5.5%)	0 of 236
Sarecycline/Sarecycline	2 of 247 (0.8%)	5 of 247 (2%)	0 of 247

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32038757Pariser 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.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Berk, MD study director

Allergan, plc

56 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sarecycline in people with Acne Vulgaris, run by Almirall, S.A. at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) (time frame: Up to 40 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02413346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.