A randomized clinical comparative study of cryotherapy plus photodynamic therapy vs. cryotherapy in the treatment of multiple condylomata acuminata.

BACKGROUND

Cryotherapy cannot destroy subclinical human papillomavirus-infected cells of condylomata acuminata (CA). The topical application of aminolevulinic acid (ALA) results in a shallow penetration depth in CA lesions (1).

OBJECTIVES

To compare the efficacy and safety of cryotherapy plus ALA-photodynamic therapy (PDT) with cryotherapy in the treatment of multiple CA.

METHODS

Eighty patients with multiple CA received cryotherapy plus ALA-PDT (n=40) or cryotherapy plus placebo-PDT (n=40). After cryotherapy, a 20% ALA or a placebo solution was applied to the CA area 3 h before illumination with red light (635 nm, 100 mW/cm(2) , 100 J/cm2). The treatment was repeated 7 days after the first treatment if the lesions were not completely resolved. The complete response rate, recurrence rate and adverse effects in the two groups were analyzed.

RESULTS

After two treatments, the complete response rates in the combined group (cryotherapy plus ALA-PDT) and cryotherapy group were 32.4% (36/111) and 32.6% (43/132) in the anal area (P>0.05), 100% (32/32) and 54.5% (18/33) in the urethral meatus (P<0.05), and 94.2% (129/137) and 50.5% (56/111) in the external genitals (P<0.05), respectively. The recurrence rates in the combined group and cryotherapy group were 24.3% (27/111) and 31.1% (41/132) in the anal area (P>0.05), 9.4% (3/32) and 39.4% (13/33) in the urethral meatus (P<0.05), and 3.6% (5/137) and 31.5% (35/111) in the external genitals (P<0.05), respectively. The adverse effects in each group included mild to moderate pain, edema, erosion and hypopigmentation, without any infection, ulcers, scarring or urethral malformations.

CONCLUSION

Cryotherapy plus ALA-PDT is a more effective regimen for the treatment of multiple CA compared with cryotherapy alone.