PMID- 31251550
OWN - NLM
STAT- MEDLINE
DCOM- 20200114
LR  - 20200114
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 18
IP  - 6
DP  - 2019 Jun 1
TI  - A Phase 2b, Randomized, Double-Blind Vehicle Controlled, Dose Escalation Study 
      Evaluating Clascoterone 0.1%, 0.5%, and 1% Topical Cream in Subjects With Facial 
      Acne.
PG  - 570
LID - S1545961619P0570X [pii]
AB  - Androgens play a key role in acne pathogenesis in both males and females. 
      Clascoterone (CB-03-01, Cortexolone 17alpha propionate) cream is a topical 
      anti-androgen under investigation for the treatment of acne. The results from a 
      phase 2b dose escalating study are discussed. Methods: Primary objective: to 
      compare the safety and efficacy of topical creams containing clascoterone 0.1% 
      (twice daily [BID]), 0.5% (BID), or 1% (daily [QD] or BID) versus vehicle (QD or 
      BID) in male and female subjects >/=12 years with facial acne vulgaris. Efficacy 
      was assessed by: Investigator's Global Assessment (IGA)--the overall severity of 
      acne using a five-point scale (from 0=clear to 4=severe); inflammatory and 
      non-inflammatory acne lesion counts (ALC); and subject satisfaction with 
      treatment--subjects assessed overall treatment satisfaction using a 4-point 
      scale. Safety assessments: local and systemic adverse events (AEs), physical 
      examination/vital signs, laboratory tests, local skin reactions (LSRs), and 
      electrocardiograms (ECGs). Treatment success required a score of "clear" or 
      "almost clear" (IGA score of 0 or 1) and a two or more-grade improvement from 
      baseline. Results: 363 subjects (N=72, 0.1% BID; N=76, 0.5% BID; N=70, 1% QD; 
      N=70, 1% BID; and N=75, vehicle QD or BID) enrolled. 304 subjects (83.7%) 
      completed the study. Intention to Treat (ITT) population: 196/363 (54.0%) 
      females; 167/363 46.0%) males; (257/363 (70.2%) were white; average age=19.7 
      years. Demographic and baseline characteristics were similar across all groups. 
      Treatment success at week 12 were highest for the 1% BID (6/70, 8.6%) and 0.1% 
      BID (6/72, 8.3%) groups versus vehicle (2/75, 2.7%). Absolute change in 
      inflammatory (P=0.0431) and non-inflammatory (P=0.0303) lesions was statistically 
      significant among the treatment groups. The median change from baseline at week 
      12 in inflammatory and non-inflammatory lesions was greatest in the 1% BID group 
      -13.5 and -17.5, respectively. Similar results were observed for the secondary 
      efficacy endpoints whereby the highest success rate and greatest reduction in 
      lesion counts from baseline to week 12 occurred with 1% BID. 93/363 subjects 
      (25.6%) reported >/=1 AEs; total number of AEs=123 with 2 probably/possibly related 
      to treatment (N=1, 1% QD group). Subjects with >/=1AEs: 0.1% BID=25.0%, 0.5% 
      BID=38.2%, 1% QD=22.9%, 1% BID=18.6%, and vehicle=22.7%. AEs were mostly mild in 
      severity and similar across all groups. Most AEs (93/121 76.8%) resolved by the 
      end of the study. Erythema was the most prevalent LSR; 36.8% had at least minimal 
      erythema at some point during the study. Conclusions: All clascoterone cream 
      concentrations were well tolerated with no clinically relevant safety issues 
      noted. Clascoterone 1% BID treatment had the most favorable results and was 
      selected as the best candidate for further clinical study and development. Two 
      Phase 3 investigations of clascoterone topical cream, 1% for the treatment of 
      moderate-to-severe acne vulgaris in individuals >/=9 years recently concluded. J 
      Drugs Dermatol. 2019;18(6):570-575.
FAU - Mazzetti, Alessandro
AU  - Mazzetti A
FAU - Moro, Luigi
AU  - Moro L
FAU - Gerloni, Mara
AU  - Gerloni M
FAU - Cartwright, Martina
AU  - Cartwright M
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Pharmaceutical Vehicles)
RN  - 0 (Propionates)
RN  - WDT5SLP0HQ (Cortodoxone)
RN  - XN7MM8XG2M (Clascoterone)
SB  - IM
MH  - Acne Vulgaris/diagnosis/*drug therapy
MH  - Adolescent
MH  - Adult
MH  - Cortodoxone/administration & dosage/adverse effects/*analogs & derivatives
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Face
MH  - Female
MH  - Humans
MH  - Male
MH  - Pharmaceutical Vehicles/administration & dosage/adverse effects
MH  - Propionates/*administration & dosage/adverse effects
MH  - Severity of Illness Index
MH  - Skin Cream/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2019/06/30 06:00
MHDA- 2020/01/15 06:00
CRDT- 2019/06/29 06:00
PHST- 2019/06/29 06:00 [entrez]
PHST- 2019/06/30 06:00 [pubmed]
PHST- 2020/01/15 06:00 [medline]
AID - S1545961619P0570X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2019 Jun 1;18(6):570.