Clinical trial · Interventional

Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis

Efficacy of Iontophoresis-assisted Ablative Fractional Laser Photodynamic Therapy With Short Incubation Time for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial

NCT02670655CI-TRIAL-00020745completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Actinic Keratosis	—	UNRESOLVED	—

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
2940-nm Er:YAG AFL pretreatment	Device	—	UNRESOLVED
Iontophoresis application	Device	—	UNRESOLVED
irradiation with red light-emitting diode lamp	Device	—	UNRESOLVED
lidocaine/prilocaine (5%) application	Drug	—	UNRESOLVED
MAL application	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Group A (short-time iontophoresis group)
description
Group A was treated with iontophoresis-assisted AFL-PDT with a short incubation time (2 h)
interventionNames
1. Drug: lidocaine/prilocaine (5%) application
2. Device: 2940-nm Er:YAG AFL pretreatment
3. Drug: MAL application
4. Device: Iontophoresis application
5. Device: irradiation with red light-emitting diode lamp
type
ACTIVE_COMPARATOR
label
Group B (short-time conventional group)
description
Group B was treated with conventional AFL-PDT with a short incubation time (2 h)
interventionNames
1. Drug: lidocaine/prilocaine (5%) application
2. Device: 2940-nm Er:YAG AFL pretreatment
3. Drug: MAL application
4. Device: irradiation with red light-emitting diode lamp

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 65 Years
Maximum age: 84 Years

Show eligibility criteria text

Inclusion Criteria:

* Korean patients aged ≥ 18 years who had biopsy-confirmed AK lesions

Exclusion Criteria:

* lactating or pregnant women
* patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
* patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment
* metal-containing device (cardiac pacemaker, orthopaedic implants, gynaecological devices)
* cardiac arrhythmia
* large skin erosion

References

Publications (0)

Data not yet available

No reference posted for this study.