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.
J Eur Acad Dermatol Venereol
; 29(2): 283-290, 2015 Feb.
Article
en En
| MEDLINE
| ID: mdl-24754379
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 (21) 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.CONCLUSION:
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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Fosfolípidos
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Rosácea
Tipo de estudio:
Clinical_trials
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Guideline
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2015
Tipo del documento:
Article