Results from a small study showed that a topical gel, called TDT 068, improved non-transient erythema in patients with erythematotelangiectatic (subtype 1) rosacea.
In the randomized trial of nearly 60 patients, German dermatologists compared TDT 068, a topical drug-free gel containing ultra-deformable Sequessome vesicles, to vehicle gel. To qualify for the study, adults age 18 to 85 had to score 6-15/30 for the primary and secondary features of the rosacea standard grading system (RSGS). The study evaluated efficacy using the patient-rated rosacea-specific quality of life instrument and investigator-rated RSGS.
The trial showed that non-transient erythema improved significantly with TDT 068 at week 4 (-0.34±0.63 vs the vehicle gel -0.05±0.51; P=0.044). Numerically greater improvements in transient erythema and telangiectasia were also observed with TDT 068 versus vehicle gel. Three treatment-related adverse events were reported but no serious events occurred with TDT 068. The overall change in quality of life, function and emotion construct scores at week 4 were comparable in both groups, but the TDT 068 group showed higher numerical increases in total RSGS scores.
Luger T, Peukert N, Rother M. 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. Published online ahead of print April 22, 2014.
Results from a small study showed that a topical gel, called TDT 068, improved non-transient erythema in patients with erythematotelangiectatic (subtype 1) rosacea.
In the randomized trial of nearly 60 patients, German dermatologists compared TDT 068, a topical drug-free gel containing ultra-deformable Sequessome vesicles, to vehicle gel. To qualify for the study, adults age 18 to 85 had to score 6-15/30 for the primary and secondary features of the rosacea standard grading system (RSGS). The study evaluated efficacy using the patient-rated rosacea-specific quality of life instrument and investigator-rated RSGS.
The trial showed that non-transient erythema improved significantly with TDT 068 at week 4 (-0.34±0.63 vs the vehicle gel -0.05±0.51; P=0.044). Numerically greater improvements in transient erythema and telangiectasia were also observed with TDT 068 versus vehicle gel. Three treatment-related adverse events were reported but no serious events occurred with TDT 068. The overall change in quality of life, function and emotion construct scores at week 4 were comparable in both groups, but the TDT 068 group showed higher numerical increases in total RSGS scores.
Luger T, Peukert N, Rother M. 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. Published online ahead of print April 22, 2014.
Results from a small study showed that a topical gel, called TDT 068, improved non-transient erythema in patients with erythematotelangiectatic (subtype 1) rosacea.
In the randomized trial of nearly 60 patients, German dermatologists compared TDT 068, a topical drug-free gel containing ultra-deformable Sequessome vesicles, to vehicle gel. To qualify for the study, adults age 18 to 85 had to score 6-15/30 for the primary and secondary features of the rosacea standard grading system (RSGS). The study evaluated efficacy using the patient-rated rosacea-specific quality of life instrument and investigator-rated RSGS.
The trial showed that non-transient erythema improved significantly with TDT 068 at week 4 (-0.34±0.63 vs the vehicle gel -0.05±0.51; P=0.044). Numerically greater improvements in transient erythema and telangiectasia were also observed with TDT 068 versus vehicle gel. Three treatment-related adverse events were reported but no serious events occurred with TDT 068. The overall change in quality of life, function and emotion construct scores at week 4 were comparable in both groups, but the TDT 068 group showed higher numerical increases in total RSGS scores.
Luger T, Peukert N, Rother M. 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. Published online ahead of print April 22, 2014.
