Abstract
OBJECTIVES: Chronic venous insufficiency (CVI) in lower limbs manifest as stasis dermatitis. The anti-collagenase, anti-inflammatory and immunomodulatory effects of doxycycline and the T-cell inhibitory effects of tacrolimus could theoretically modify the disease pathophysiology. This study was undertaken to evaluate the efficacy and safety of four weeks combination therapy of oral doxycycline 100 mg with topical tacrolimus 0.1% for stasis dermatitis associated with CVI. MATERIALS AND METHODS: A single-arm, interventional pilot study was conducted on subjects with CVI of C4 to C6 category (CEAP classification: clinical, etiology, anatomical, pathophysiology). Treatment duration was four weeks with fortnightly follow-ups. Primary efficacy was assessed as changes from baseline of pigmentation, erythema, edema, itching and hair loss of the affected area evaluated on Likert scale scores. Secondary efficacy parameters were percentage improvement of the dermatitis area and changes in ulcer dimensions (maximum length and breadth), if present. Safety evaluation included all treatment emergent clinical signs and symptoms reported by the patients and/or observed by the physician. RESULTS: Out of 19 recruited subjects, 15 completed the study for analysis. Significant (P<0.01) improvement in pain, edema, pigmentation, erythema and exudation were observed. Reduction of ulcer dimensions was also statistically significant (P<0.01). 86.6% showed improvement of the dermatitis area, 6.7% patients failed to show any improvement and 6.7% showed worsening. Adverse effects were observed in only two subjects. CONCLUSION: This pilot study suggests efficacy of this combination therapy in controlling features of stasis dermatitis but further studies are needed for validation.