Phase 3
Completed N=968
Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Source: ClinicalTrials.gov NCT02320149 ↗Enrolled (actual)
968
Serious AEs
0.8%
Results posted
May 2018
Primary outcomePrimary: Absolute Change in Facial Inflammatory Lesion Counts at Week 12 — -15.3; -10.1 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 This can indicate results are unpublished — a known publication-bias signal.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 1.5mg/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 in Facial Inflammatory Lesion Counts at Week 12 |
-15.3; -10.1 | < 0.0001 sig |
| PRIMARY Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12 |
21.9; 10.5 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 |
-51.8; -35.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 |
-47.4; -34.9 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 |
-42.2; -28.9 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 |
-29.6; -22.4 | 0.0003 sig |
| SECONDARY Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9 |
-13.9; -10.0 | < 0.0001 sig |
| SECONDARY Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6 |
-12.5; -8.4 | < 0.0001 sig |
| SECONDARY Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3 |
-8.5; -6.4 | 0.0005 sig |
| SECONDARY Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 |
-27.0; -22.7 | 0.5786 |
| SECONDARY Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 |
-20.8; -18.0 | 0.6969 |
| SECONDARY Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 |
-14.6; -17.6 | 0.7377 |
| SECONDARY Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 |
-8.0; -14.3 | 0.2861 |
| SECONDARY Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12 |
-15.1; -11.2 | 0.0014 sig |
| SECONDARY Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9 |
-13.0; -9.6 | 0.0010 sig |
| SECONDARY Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6 |
-10.6; -8.6 | 0.0371 sig |
| SECONDARY Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3 |
-7.9; -7.1 | 0.3806 |
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
- 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 received 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 (NCT02320149). 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.