PMID- 36381182
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221117
IS  - 1941-2789 (Print)
IS  - 2689-9175 (Electronic)
IS  - 1941-2789 (Linking)
VI  - 15
IP  - 11
DP  - 2022 Nov
TI  - Effective Treatment of Inflammatory Lesions of Rosacea with Subantibiotic Dose 
      Doxycycline Irrespective of Patient Weight or Baseline Lesion Count Severity.
PG  - 69-74
AB  - OBJECTIVE: Subantibiotic dose doxycycline (SDD40), formulated as a 
      modified-release 40mg capsule administered once daily, is used to treat 
      inflammatory lesions of rosacea. In order to investigate whether the patient's 
      weight or lesion severity impacts clinical outcomes with using SDD40, the 
      efficacy and safety of SDD40 in treating rosacea were evaluated in randomized 
      controlled studies (RCTs). METHODS: Phase II, III, and IV RCTs, and a subsequent 
      meta-analysis were described. For all studies, the primary efficacy endpoint was 
      the change in total inflammatory lesion count (papules, pustules, and nodules) 
      from baseline to Week 16. For one of the studies, body weights were categorized 
      by BMI (body mass index). Secondary efficacy endpoints included the change in 
      Investigator's Global Assessment (IGA). Safety was assessed by monitoring adverse 
      events (AEs). RESULTS: The efficacy of SDD40 was consistent across the studies 
      (two trials including n=72 and n=91 subjects) and meta-analysis (n=127 and 
      n=142). SDD40 remained effective regardless of baseline disease severity and 
      weight (with a weak correlation coefficient below 0.75); overweight or obese 
      subjects with severe rosacea cleared at least as well if not better than those 
      with a normal BMI and mild disease. The treatment was well tolerated with no to 
      minimal gastrointestinal-related AEs. LIMITATIONS: Retrospective analyses have 
      methodological limitations. CONCLUSION: Consistency between study results 
      including the meta-analysis supports the effectiveness and safety of SDD40, 
      irrespective of the weight of the patient or rosacea severity based on 
      inflammatory lesion count at baseline.
CI  - Copyright (c) 2022. Matrix Medical Communications. All rights reserved.
FAU - Del Rosso, James Q
AU  - Del Rosso JQ
AD  - Dr. Del Rosso is with JDR Dermatology Research and Thomas Dermatology in Las 
      Vegas, Nevada, and Advanced Dermatology and Cosmetic Surgery in Maitland, 
      Florida.
FAU - York, Jean Philippe
AU  - York JP
AD  - Dr. York is with Galderma Laboratories, L.P. in Dallas, Texas.
FAU - Bhatia, Neal
AU  - Bhatia N
AD  - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Clin Aesthet Dermatol
JT  - The Journal of clinical and aesthetic dermatology
JID - 101518173
PMC - PMC9651154
OTO - NOTNLM
OT  - antimicrobial resistance
OT  - body mass index (BMI)
OT  - inflammatory lesions of rosacea
OT  - obesity
OT  - subantibiotic dose oral doxycycline (SDD40)
OT  - subantimicrobial-dose oral doxycycline
COIS- DISCLOSURES: Dr. Del Rosso is a research investigator, consultant, and speaker 
      for Galderma. Dr. York is an employee of Galderma Laboratories. Dr. Bhatia is a 
      research investigator, consultant, and speaker for Galderma.
EDAT- 2022/11/17 06:00
MHDA- 2022/11/17 06:01
PMCR- 2022/11/01
CRDT- 2022/11/16 02:49
PHST- 2022/11/16 02:49 [entrez]
PHST- 2022/11/17 06:00 [pubmed]
PHST- 2022/11/17 06:01 [medline]
PHST- 2022/11/01 00:00 [pmc-release]
PST - ppublish
SO  - J Clin Aesthet Dermatol. 2022 Nov;15(11):69-74.