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.
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.
Torok
Helen
H
Trillium Creek Dermatology, Inc, Medina, OH 44526, USA. helenmtorok@aol.com
Taylor
Susan
S
Baumann
Leslie
L
Jones
Terry
T
Wieder
Joshua
J
Lowe
Nicholas
N
Jarret
Michael
M
Rich
Pheobe
P
Pariser
David
D
Tschen
Eduardo
E
Martin
Dale
D
Menter
Alan
A
Weiss
Jonathan
J
D000287:Administration, Topical; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007641:Keratolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
D003879:Dermatologic Agents; D004338:Drug Combinations; D006873:Hydroquinones; D007641:Keratolytic Agents; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone