Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris.
J Drugs Dermatol
; 23(1): 1278-1283, 2024 Jan 01.
Article
in En
| MEDLINE
| ID: mdl-38206145
ABSTRACT
BACKGROUND:
Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 12 years or older based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged 12 years or older with acne vulgaris from the pivotal trials (NCT02608450 and NCT02608476) and long-term extension (LTE) study (NCT02682264) is reported.METHODS:
In the pivotal trials, patients with moderate-to-severe acne vulgaris were randomized 11 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could then enter the LTE study, where all patients applied clascoterone to the face and, if desired, trunk for up to 9 additional months. Efficacy was assessed from treatment success based on Investigator's Global Assessment scores (IGA 0/1) in patients aged 12 years or older in the intention-to-treat population; lesion counts were assessed through week 12. Missing data were handled using multiple imputation in the pivotal studies and were not imputed in the LTE study.RESULTS:
Of 1421 patients enrolled, 1143 (clascoterone, 576; vehicle, 567) completed week 12; 600 entered and 343 completed the LTE study. The treatment success rate and most lesion count reductions following clascoterone vs placebo treatment reached statistical significance at week 12; the overall treatment success rate increased to 30.2% for facial acne after 12 months and 31.7% for truncal acne after 9 months of treatment.CONCLUSIONS:
The efficacy of clascoterone cream 1% for the treatment of acne vulgaris continued to increase over time for up to 12 months in patients aged 12 years or older with acne vulgaris. J Drugs Dermatol. 2024;23(1)1278-1283. doi10.36849/JDD.7719.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Propionates
/
Acne Vulgaris
/
Plastic Surgery Procedures
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Humans
Language:
En
Journal:
J Drugs Dermatol
Journal subject:
DERMATOLOGIA
Year:
2024
Type:
Article