Phase 2
N=70
Efficacy and Safety of CD5024 1% in Acne Vulgaris
Acne
Bottom Line
View on ClinicalTrials.gov: NCT03034460 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Inflammatory Lesion Count (Papules and Pustules) at Day 40 — 10.1; 8.9; 6.1; 9.4 lesion count — p== 0.158
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CD5024 1% cream (Drug); CD5024 cream placebo (Drug); CD0271/CD1579 gel (Drug); CD0271/CD1579 gel placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammatory Lesion Count (Papules and Pustules) at Day 40 |
10.1; 8.9; 6.1; 9.4 | = 0.158 |
| SECONDARY Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) |
16.5; 17.5; 17.6; 16.6 | — |
| SECONDARY Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 |
35.7; 44.4; 65.5; 42.5 | — |
| SECONDARY Total Lesion Count at Baseline (Day 1) and Day 40 |
37.7; 39.4; 37.3; 36.4; 26.4; 25.9 | — |
| SECONDARY Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40 |
32.5; 34.0; 50.2; 27.8 | — |
| SECONDARY Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 |
21.1; 21.8; 19.6; 19.6; 16.2; 16.9 | — |
| SECONDARY Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 |
27.8; 21.3; 36.9; 11.7 | — |
| SECONDARY Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 |
0; 4; 16; 7; 16; 6 | — |
| SECONDARY Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 |
2; 2; 11; 11; 15; 4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
32; 14 | — |
| SECONDARY Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) |
37; 38; 8; 15; 9; 9 | — |
Summary
Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.
Eligibility Criteria
Inclusion Criteria
- The subject is a male or a female aged from 18 to 35 years old at screening visit.
- The subject has a medical diagnosis of acne vulgaris :
2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at Baseline
2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline
- If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study
Exclusion Criteria
- The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).
- The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
- The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label).
- The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).
Data sourced from ClinicalTrials.gov (NCT03034460). 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.