Phase 3
Completed N=1,034
Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Source: ClinicalTrials.gov NCT02322866 ↗Enrolled (actual)
1,034
Serious AEs
0.5%
Results posted
May 2018
Primary outcomePrimary: Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 — -10.7; -15.1 lesion count — p=< 0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 |
-10.7; -15.1 | < 0.0001 sig |
| PRIMARY Percentage of Participants With Investigator's Global Assessment (IGA) Scale Success at Week 12 |
15.3; 22.6 | 0.0038 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 |
-35.4; -49.9 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 |
-31.9; -44.5 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 |
-27.3; -39.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 |
-18.6; -28.0 | < 0.0001 sig |
| SECONDARY Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 |
-9.5; -13.4 | < 0.0001 sig |
| SECONDARY Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 |
-8.0; -11.7 | < 0.0001 sig |
| SECONDARY Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 |
-5.5; -8.4 | < 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent or assent form
- Male/female, 9 to 45 years of age, inclusive
- Body weight between 33 and 136 kg, inclusive
- Facial acne vulgaris with:
- 20-50 inflammatory lesions (papules, pustules and nodules)
- 30-100 noninflammatory lesions (open and closed comedones)
- No more than 2 nodules
- Investigator's Global Assessment (IGA) score of moderate (3) or severe (4)
- Negative urine pregnancy test at baseline - females of childbearing potential
- Agrees to use an effective method of contraception throughout the study
- Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
- Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI).
Exclusion Criteria
- Has a dermatological condition of the face 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 receive any of the following treatments within 12 weeks of screening:
- Systemic retinoids
- Systemic corticosteroids
- Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
- Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
- Has used any acne affecting treatment without an appropriate washout period
- Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
- Is pregnant, lactating or 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, Cushings 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 screening 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.
Data sourced from ClinicalTrials.gov (NCT02322866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.