A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads.

Helen Torok, Susan Taylor, Leslie Baumann, Terry Jones, Joshua Wieder, Nicholas Lowe, Michael Jarret, Phoebe Rich, David Pariser, Eduardo Tschen, Dale Martin, Alan Menter, Jonathan Weiss

Research output: Contribution to journalArticle

42 Citations (Scopus)

Abstract

This was a 12-month extension of a randomized, investigator-blinded, multicenter, 8-week trial with triple combination (TC) cream in facial melasma. A total of 585 patients were enrolled in the study and 569 patients received study medication. Three hundred eighty-nine patients completed 6 months of treatment and 327 patients completed 12 months of treatment. TC cream demonstrated a favorable safety profile: only 14 patients (2.5%) discontinued the study due to treatment-related adverse events (AEs). The 2 cases of skin atrophy were mild and did not lead to withdrawal. From the 23 cases of mild telangiectasia, only 2 resulted in discontinuation. All others were transient. Results confirmed those of a previous smaller study, with both physicians and patients reporting clinically significant improvements in melasma. By month 12, 80% of patients had lesions completely cleared or nearly cleared. Once daily application of TC cream applied intermittently over a long period is a safe, tolerable, and effective treatment for moderate to severe melasma of the face.

Original languageEnglish (US)
Pages (from-to)592-597
Number of pages6
JournalJournal of drugs in dermatology : JDD
Volume4
Issue number5
StatePublished - Jan 1 2005
Externally publishedYes

Fingerprint

Melanosis
Safety
Telangiectasis
Therapeutics
Atrophy
Research Personnel
Physicians
Skin

ASJC Scopus subject areas

  • Dermatology

Cite this

A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads. / Torok, Helen; Taylor, Susan; Baumann, Leslie; Jones, Terry; Wieder, Joshua; Lowe, Nicholas; Jarret, Michael; Rich, Phoebe; Pariser, David; Tschen, Eduardo; Martin, Dale; Menter, Alan; Weiss, Jonathan.

In: Journal of drugs in dermatology : JDD, Vol. 4, No. 5, 01.01.2005, p. 592-597.

Research output: Contribution to journalArticle

Torok, H, Taylor, S, Baumann, L, Jones, T, Wieder, J, Lowe, N, Jarret, M, Rich, P, Pariser, D, Tschen, E, Martin, D, Menter, A & Weiss, J 2005, 'A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads.', Journal of drugs in dermatology : JDD, vol. 4, no. 5, pp. 592-597.
Torok, Helen ; Taylor, Susan ; Baumann, Leslie ; Jones, Terry ; Wieder, Joshua ; Lowe, Nicholas ; Jarret, Michael ; Rich, Phoebe ; Pariser, David ; Tschen, Eduardo ; Martin, Dale ; Menter, Alan ; Weiss, Jonathan. / A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads. In: Journal of drugs in dermatology : JDD. 2005 ; Vol. 4, No. 5. pp. 592-597.
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abstract = "This was a 12-month extension of a randomized, investigator-blinded, multicenter, 8-week trial with triple combination (TC) cream in facial melasma. A total of 585 patients were enrolled in the study and 569 patients received study medication. Three hundred eighty-nine patients completed 6 months of treatment and 327 patients completed 12 months of treatment. TC cream demonstrated a favorable safety profile: only 14 patients (2.5{\%}) discontinued the study due to treatment-related adverse events (AEs). The 2 cases of skin atrophy were mild and did not lead to withdrawal. From the 23 cases of mild telangiectasia, only 2 resulted in discontinuation. All others were transient. Results confirmed those of a previous smaller study, with both physicians and patients reporting clinically significant improvements in melasma. By month 12, 80{\%} of patients had lesions completely cleared or nearly cleared. Once daily application of TC cream applied intermittently over a long period is a safe, tolerable, and effective treatment for moderate to severe melasma of the face.",
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