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GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA
A Journal on Dermatology and Sexually Transmitted Diseases
Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,014
Giornale Italiano di Dermatologia e Venereologia 2002 June;137(3):217-24
Double-blind clinical study of a topical preparation versus placebo in women with edematofibrous panniculopathy localized in the thighs
Galbiati G. 1, Righini V. 2, Renzetti D. 3, Bevilacqua M. 2
1 Azienda Ospedaliera S. Gerardo dei Tintori, Monza U.O. di Dermosifilopatia
2 Azienda Ospedaliera L. Sacco, Milano U. O. di Endocrinologia
3 Pulsar sas, Studi Clinici e Biometrici, Monza
Background. To test in a randomized, parallel double-blind study versus placebo, the tolerability and the anticellulitic efficacy of a commercially available drug for topical use containing l-thyroxine as active ingredient, in compliance with the Good Clinical Practice and the principles of Helsinki Declaration.
Methods. The trial was carried-out in two study centers on 114 women with edematofibrous panniculopathy localized in the thighs, who met the criteria of selection and who gave their free informed consent to take part in the study. The trial lasted 17 weeks, including two periods of treatment of 4 weeks each, 1 week of pre-treatment (run-in), 4 weeks of wash-out between the two periods of treatment and 4 weeks of follow-up. In the steps of treatment, the study drugs were applied on the thighs once daily, in the evening, with a naked-hand massage of 10-15 minutes. The drug efficacy was assessed basing on the patient’s evaluation of the anticellulitic activity and on the variation of the circumference in cm of the thighs, measured at a prefixed level. The above detections were carried-out during the 12 next out-patient visits. Tolerability was evaluated on the basis of biohumoral routine data, serum hormonal examinations (T3, T4, FT3, FT4, TSH), vital signs (Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate), the onset of adverse events and the patient’s evaluation.
Results. The drug was found to be clinically and statistically more active than the placebo (p<0.01) on the main parameter of activity (subjective evaluation) as well as on the secondary parameter of activity (thigh circumference). The mean activity showed a progressive pattern in time in both the first and second periods of treatment, with a maximum at the end of the second period. In the wash-out and follow-up steps a mild trend towards the regression of the results was found in both groups. Drug tolerability was good and not different from the one of the placebo in all the evaluated variables, included the serum hormonal levels. Only 4 cases (3.5%) exhibited moderate irritative skin reactions on the treated area, which were evaluated as correlated with the treatment and resolved spontaneously at the discontinuation of the topical administration of the preparations. Three cases were treated with the drug and one with the placebo.
Conclusions. Topical application of the drug showed a higher efficacy than with placebo (p<0.01) and a good local and systemic tolerability even in long-term treatments with repeated cycles, without remarkable differences versus placebo.