Efficacy and safety of a new topical keratolytic treatment for localized hyperkeratosis in adults.
BACKGROUND
Palmoplantar keratoderma (PPK) is a heterogeneous group of skin disorders characterized by symmetrical diffuse or patchy areas of hyperkeratosis on the palms and soles. This study aimed to evaluate the efficacy and safety of a topical keratolytic treatment for localized hyperkeratosis.


METHODS
International, randomized, vehicle-controlled, double-blind, intra-individual comparative study.


RESULTS
Clinical signs assessed by the investigator significantly improved in both group from baseline to day 10 and day 21 (P<0.001). Mean improvement was significantly more marked on the treated side than the control side (except pruritus) at day 10 for hyperkeratosis (-0.58 ± 0.59 versus -0.41 ± 0.51, P=0.009), desquamation (-0.62 ± 0.69 versus -0.47 ± 0.67, P=0.042) and dryness (-0.75 ± 0.67 versus -0.57 ± 0.67, P=0.014). At day 21, dryness (-1.16 ± 0.80 versus -1.00 ± 0.79, P=0.036) was significantly improved but only a trend for hyperkeratosis (-0.86 ± 0.76 versus -0.72 ± 0.72, P=0.158) and desquamation (-0.83 ± 0.85 versus -0.65 ± 0.85, P=0.057) was observed. Tolerance was considered to be good or very good in more than 92 percent patients. Both patients and investigators were satisfied in more than 84 percent of cases with the topical keratolytic treatment efficacy. Safety profile was highly satisfactory.


CONCLUSIONS
This topical keratolytic treatment represents a valuable first-line option for mild to moderate hyperkeratosis.
Sadick Dermatology, New York, NY, USA.
Neil S
NS
Sadick
Christine
C
Coutanceau
Vincent
V
Sibaud
Christelle
C
Merial-Kieny
D000287:Administration, Topical; D000328:Adult; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D004361:Drug Tolerance; D005060:Europe; D005260:Female; D006801:Humans; D007645:Keratoderma, Palmoplantar / Q000188:drug therapy*; D007641:Keratolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D019344:Lactic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D020156:Salicylic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D012871:Skin Diseases / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States; D014508:Urea / Q000009:adverse effects / Q000627:therapeutic use*
D007641:Keratolytic Agents; D019344:Lactic Acid; D014508:Urea; D020156:Salicylic Acid