Phase 2
Completed N=662
Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
Source: ClinicalTrials.gov NCT01320033 ↗Enrolled (actual)
662
Serious AEs
1.1%
Results posted
Feb 2020
Primary outcomePrimary: Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) — -16.1; -12.9; -12.6 lesion count — p=0.006
Summary
The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) |
-16.1; -12.9; -12.6 | 0.006 sig |
| SECONDARY Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF]) |
14.4; 13.8; 7.7 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) |
-48.6; -40.3; -37.1 | — |
| SECONDARY Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) |
-38.3; -27.8; -27.8 | — |
| SECONDARY Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) |
-10.0; -5.2; -5.8 | — |
| SECONDARY Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16 |
1.6; 1.5; 1.5; 1.2; 1.2; 1.1 | — |
| SECONDARY Number of Participants With at Least One Adverse Event (AE) |
63; 83; 89 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects 12 years of age or older
- acne vulgaris with facial involvement
- A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory)
- 25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)
Exclusion Criteria
- More than two acne nodules/cysts on the face
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment
- Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea
- Beard or facial hair which might interfere with study assessments
- planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp)
- Use of oral contraceptives solely for control of acne
- Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5 times above upper limit of normal
- Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher
- Presence of oral or genital candidiasis or history of multiple episodes of oral or genital candidiasis
- Females who intend to conceive a child within 5 months following Baseline visit
- Males who intend to conceive a child with partner during the study period
- Requiring concomitant use of methoxyflurane
Data sourced from ClinicalTrials.gov (NCT01320033). 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.