Phase 2
Completed N=304
Dose Range Study of CD5789 in Acne Vulgaris
Source: ClinicalTrials.gov NCT01616654 ↗Enrolled (actual)
304
Serious AEs
1.0%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants With Success Rate 1 (SR1) — 29.51; 32.79; 26.67; 32.79 percentage of participants — p=0.096
Summary
To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Success Rate 1 (SR1) |
29.51; 32.79; 26.67; 32.79; 16.39 | 0.096 |
| PRIMARY Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF) |
-53.61; -54.75; -54.99; -59.84; -46.87 | 0.108 |
| PRIMARY Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF) |
-47.59; -49.87; -50.72; -55.07; -40.48 | 0.067 |
| SECONDARY Percentage of Participants With Success Rate 2 (SR2) |
13.11; 14.75; 16.67; 21.31; 8.20 | — |
| SECONDARY Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF) |
-19.67; -21.11; -19.32; -21.03; -17.74; -24.30 | — |
| SECONDARY Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF) |
-49.16; -53.14; -51.93; -53.09; -41.70; -46.34 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participant, 12 to 35 years old with the following characteristics:
- Facial acne severity grade of the following:
- Stratum 1: IGA score of 3 or 4
- Stratum 2: IGA score of 4
- Stratum 3: IGA score of 3 or 4
- A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:
- Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
- Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
- Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.
- Note: Participants of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.
Exclusion Criteria
- The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant participates in the clinical trial.
- Known or suspected allergies or sensitivities to any components of any of the study drugs.
- Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.
Data sourced from ClinicalTrials.gov (NCT01616654). 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.