Efficacy of Topical Calcipotriol-assisted Ablative Fractional Laser Photodynamic Therapy for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial

NCT02976727 Phase 1 COMPLETED

Vitamin D(Vit D) is a pro-differentiation agent that enhances the accumulation of protoporphyrin IX (PpIX) after MAL(methyl-aminolevulinate) incubation in actinic keratosis and may have significant benefit for the treatment of actinic keratosis by ablative fractional laser-primed photodynamic therapy (AFL-PDT).

Details

Lead sponsor	Dong-A University
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2014-05
Completion	2015-08

Conditions

• Actinic Dermatosis

Interventions

• Topical Vitamin D (Calcipotriol) application
• Placebo cream application
• lidocaine/prilocaine (5%) application
• 2940-nm Er:YAG AFL pretreatment
• MAL application
• Measurements of the fluorescence intensity
• irradiation with red light-emitting diode lamp

Primary outcomes

• Differences of short-term complete response rates between VitD-AFL-PDT and AFL-PDT — Short-term complete response rates were evaluated at 3 months after treatment
  Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a noncomplete response (incomplete disappearance)
• Differences of long-term complete response rates between VitD-AFL-PDT and AFL-PDT — Long-term complete response rates were evaluated at 12 months
  In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.
• Difference of the recurrence rates between VitD-AFL-PDT and AFL-PDT — Recurrence rates were evaluated respectively at 12 months after treatment.
  In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.

Countries

South Korea