TMFI Enhances Skin Surface and Epidermal PpIX Fluorescence

NCT04221126 | Completed Phase 4 DMC

• 1 other identifier: 2018-004397-96
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates a relatively new device TMFI and incubation of ALA in a cream-vehicle and a gel-vehicle.

Conditions

Normal Skin

Keywords

protoporphyrin ix; 5-aminolevulinic acid; thermo-mechanical intervention; normal skin

Outcome Measures

Primary Outcomes (2)

• Change in PpIX fluorescence at skin surface following TMFI and topical 5-ALA in gel and cream vehicle

  Levels of PpIX uptake at the skin surface quantitatively from PpIX imaging.

  Baseline and in 30-minute intervals until 3 hours

• PpIX fluorescence biodistribution inside skin

  Levels of PpIX uptake inside predefined skin regions: Epidermis, superficial dermis, mid dermis and deep dermis evaluated on fluorescence microscopy images. Biopsies used for fluorescence microscopy was sampled after 3 hours.

  3 hours

Secondary Outcomes (6)

• Histological skin interactions after TMFI

  3 hours

• Severity of local skin reactions

  5 minutes after TMFI pretreatment

• Severity of local skin reactions

  3 hours after TMFI pretreatment

• Severity of local skin reactions

  14 days after TMFI pretreatment

• Presence of perceived pain during treatment

  During the actual TMFI pretreatment, estimated 1-2 minute per participant

Study Arms (5)

TMFI +cream

EXPERIMENTAL

TMFI + ALA cream

Device: TMFI; Drug: ALA cream

TMFI + gel

EXPERIMENTAL

TMFI + ALA gel

Device: TMFI; Drug: ALA gel

ALA creAM

ACTIVE COMPARATOR

ALA cream

Drug: ALA cream

ALA GEL

ACTIVE COMPARATOR

ALA gel

Drug: ALA gel

Control

NO INTERVENTION

Untreated control with no intervention

Interventions

TMFI DEVICE

Tixel rapidly transfer thermal energy by a metallic pyramid tip that enable skin contact through integrated pulsed movements. The rapid heating dehydrates he epidermis and superficial dermis and creates micropores with no coagulative damage of surronding tissue.

Also known as: Thermo-mechanical fractional injury

TMFI + gel; TMFI +cream

ALA cream DRUG

ALA compounded in a cream

Also known as: 5-aminolevulinic acid compounded in a cream

ALA creAM; TMFI +cream

ALA gel DRUG

ALA compounded in a gel

Also known as: 5-aminolevulinic acid compounded in a gel

ALA GEL; TMFI + gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fitzpatrick skin type I-III and normal skin on the upper back
• Fertile women with negative U-hCG and use of safe anticontraceptive during the entire study period e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation or hormonal vaginal ring
• Provided informed written consent

You may not qualify if:

• No previous PDT or laser treatment within the past 6 months in the study areas
• Pregnant or lactating women
• Participants with known allergy to 5-ALA, lidocaine or any excipients to components in the vehicles
• Considered unable to follow the study protocol

Sponsors & Collaborators

• Merete Haedersdal: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

Study Officials

• Merete Hædersdal, DMSc

  Bispebjerg Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Dr. med, Professor

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 9, 2020
• Study Start: April 29, 2019
• Primary Completion: August 8, 2019
• Study Completion: December 9, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)