Pretreatments of the Skin Prior to PDT

Bispebjerg Hospital

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MAL Control.; Other: Untreated Control; Procedure: Sandpaper pretreatment + MAL-PDT; Procedure: Curettage pretreatment + MAL-PDT; Procedure: Microneedle pretreatment + MAL-PDT; Procedure: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT; Procedure: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT

Study type: Interventional

Funder types: Other

Identifiers

NCT02372370

H-3-2014-132

Details and patient eligibility

About

The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT).

Full description

The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT). The pretreatments include: microneedling, sandpaper, curettage, ablative fractional laser and non-ablative fractional laser. 17 treatment areas are mapped on the upper back of the participants. Each participant receives each intervention in a random sequence.

Primary outcome measure: PpIX accumulation after 3 hours incubation with MAL. Secondary outcome measures: pain during treatment and skin reactions.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older, healthy, fair skinned (skin type I-III)

Exclusion criteria

• Pregnant women
• Tattoos, moles or scars in treatment area

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Interventions

Active Comparator group

Description:

All participants receive all interventions.

Treatment:

Procedure: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT

Procedure: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT

Drug: MAL Control.

Other: Untreated Control

Procedure: Sandpaper pretreatment + MAL-PDT

Procedure: Curettage pretreatment + MAL-PDT

Procedure: Microneedle pretreatment + MAL-PDT