Phase 2
Completed N=285
Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris
Source: ClinicalTrials.gov NCT01628549 ↗Enrolled (actual)
285
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit — 12.8; 14.4; 17.6; 17.1 Number of Inflammatory Lesions — p=0.4344
Summary
To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit |
12.8; 14.4; 17.6; 17.1 | 0.4344 |
| PRIMARY The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit |
8; 11; 17; 10; 64; 65 | 0.3300 |
| SECONDARY The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit |
5.8; 5.4; 5.4; 5.9; 8.4; 8.5 | — |
| SECONDARY The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit |
5.4; 3.8; 4.3; 5.1; 10.6; 9.4 | — |
| SECONDARY The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit |
19.3; 17.2; 17.8; 19.4; 25.6; 26.4 | — |
| SECONDARY The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit |
9.7; 7.7; 8.3; 10.6; 19.0; 16.7 | — |
| SECONDARY The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 |
0; 3; 0; 1; 72; 73 | — |
Eligibility Criteria
Inclusion Criteria
- if women of child-bearing potential, have a negative urine pregnancy test
- Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
- Male or female, 12-45 years of age with body weight between 52 and 88 kg
- Diagnosis of acne vulgaris with:
20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)
- No more than 2 nodules on the face
- Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)
Exclusion Criteria
- Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:
Within 1 week prior to randomization:
- Medicated facial cleansers
- Topical acne treatments (other than those listed below)
Within 4 weeks prior to randomization:
- Topical retinoids
- Topical anti-inflammatories and corticosteroids
- Systemic antibiotics
- Systemic acne treatments
Within 12 weeks prior to randomization:
- Systemic retinoids
- Systemic corticosteroids
- Pseudomembranous colitis or antibiotic-associated colitis
- Hepatitis, liver damage or renal impairment
Data sourced from ClinicalTrials.gov (NCT01628549). 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.