title: A multicentre, randomized, placebo-controlled trial establishing the treatment effect of TDT 068, a topical formulation containing drug-free ultra-deformable phospholipid vesicles, on the primary features of erythematotelangiectatic rosacea.
abstract: BACKGROUND
  Rosacea subtype 1 (erythematotelangiectatic) is an inflammatory skin disease with limited treatment options. TDT 068, a topical drug-free gel containing ultra-deformable Sequessome vesicles, is registered for use in inflammatory skin conditions, but has not been investigated in rosacea.
  
  
  OBJECTIVE
  This postmarketing study aimed to substantiate the effects of TDT 068 in rosacea subtype 1.
  
  
  METHODS
  Patients aged 18-85 scoring 6-15/30 for the primary and secondary features of the rosacea standard grading system (RSGS) were enrolled. Following stratification (four females/one male) patients were randomized (2:1) to receive TDT 068 or vehicle gel for 4 weeks. Efficacy was evaluated using the patient-rated rosacea-specific quality of life (R-QOL) instrument and investigator-rated RSGS. Adverse events (AEs) were monitored throughout.
  
  
  RESULTS
  Of the 61 randomized patients, 58 were eligible for the full analysis set per protocol. Baseline characteristics were balanced across the groups. R-QOL symptom construct scores improved slightly from baseline to Week 4 in both groups (-0.04 ± 0.51 TDT 068 vs. -0.22 ± 0.59 vehicle; P = 0.1990). Changes in R-QOL total, function and emotion construct scores at Week 4 were similar with TDT 068 and vehicle, but TDT 068 yielded numerically greater increases in total RSGS scores (-1.55 ± 1.83 vs. -0.75 ± 2.38 vehicle; P = 0.105). Non-transient erythema improved significantly with TDT 068 at Week 4 (-0.34 ± 0.63 vs. -0.05 ± 0.51 vehicle; P = 0.044), with ≥1 grade improvement in 35% of patients (vs. 15% vehicle; P = 0.039). Numerically greater improvements in transient erythema and telangiectasia were also seen with TDT 068. Three treatment-related AEs were reported but no serious AEs occurred.
  
  
  CONCLUSIONS
  These data, based on investigator assessment, provide evidence for the good tolerability of drug-free TDT 068 as well as modest improvements in the symptoms of erythematotelangiectatic rosacea.
authors.affiliation: Department of Dermatology, University Clinics, Münster, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Luger
authors.affiliation: Dermatology, Aestheso, Münster, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Peukert
authors.affiliation: IMR Partner GmbH, Munich, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Rother
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010743:Phospholipids / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D012393:Rosacea / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D010743:Phospholipids; D010919:Placebos; C000601994:TDT 068
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