Impact of thermo-mechanical intervention on normal skin

Impact of thermo-mechanical intervention on Protoporphyrin IX accumulation and biodistribution in normal skin following topical 5-aminolevulinic acid at high and low vehicle viscosity

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004397-96-DK

Enrollment

Registered

2019-01-29

Start date

2019-04-09

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy skin on the upper back on 3 participants in study a and 12 participants in study b. MedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Gliolan Pharmaceutical Form: Powder and solvent for oral solution INN or Proposed INN: AMINOLEVULINIC ACID CAS Number: 106-60-5 Other descriptive name: Gliolan Concentration unit: % (W/W)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Healthy participants above 18 years of age • Fitzpatrick skin type I-III and normal skin on the upper back • Fertile women with negative U-hCG and with 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The study comprises two parts: A) A pre-study including 3-4 healthy participants to determine the optimal duration of 5-ALA incubation to visualize PpIX fluorescence microscopy. B) The aim of study B is to assess the impact of i) TMI exposure and ii) a low- and high-viscosity vehicle formulation on 5-ALA-induced PpIX fluorescence at skin surface and skin biodistribution within skin layers. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is PpIX fluorescence intensity measured at skin surface and PpIX fluorescence intensity and biodistribution within skin, following TMI and topical 20% 5-ALA in a low viscosity vehicle and high viscosity vehicle. ;Timepoint(s) of evaluation of this end point: At treatment day and within 6 months from study approval.	—

Measure

Time frame

Main Objective: The study comprises two parts: A) A pre-study including 3-4 healthy participants to determine the optimal duration of 5-ALA incubation to visualize PpIX fluorescence microscopy. B) The aim of study B is to assess the impact of i) TMI exposure and ii) a low- and high-viscosity vehicle formulation on 5-ALA-induced PpIX fluorescence at skin surface and skin biodistribution within skin layers. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is PpIX fluorescence intensity measured at skin surface and PpIX fluorescence intensity and biodistribution within skin, following TMI and topical 20% 5-ALA in a low viscosity vehicle and high viscosity vehicle. ;Timepoint(s) of evaluation of this end point: At treatment day and within 6 months from study approval.

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Secondary

Measure	Time frame
Secondary end point(s): I. Histology tissue effects immediately after TMI: Punch skin biopsies obtained 3 hours after TMI, evaluating histologic changes in the epidermis and dermis from hematoxylin-eosin stained histology-slides. The micropores are evaluated on a standardized term of depth, size and form. II. Skin reactions to TMI: Clinically graded as edema, erythema, scaling, pustules and crusting on a 4-point categorical scale as none, mild, moderate and serve. III. Pain during TMI: Participant evaluated pain on a numerical rating scale (NRS) from 0-10 at 1-point increments; 0 being no perceivable pain and 10 being worst imaginable pain. ;Timepoint(s) of evaluation of this end point: At treatment day and within 6 months from study approval.	—

Measure

Time frame

Secondary end point(s): I. Histology tissue effects immediately after TMI: Punch skin biopsies obtained 3 hours after TMI, evaluating histologic changes in the epidermis and dermis from hematoxylin-eosin stained histology-slides. The micropores are evaluated on a standardized term of depth, size and form. II. Skin reactions to TMI: Clinically graded as edema, erythema, scaling, pustules and crusting on a 4-point categorical scale as none, mild, moderate and serve. III. Pain during TMI: Participant evaluated pain on a numerical rating scale (NRS) from 0-10 at 1-point increments; 0 being no perceivable pain and 10 being worst imaginable pain. ;Timepoint(s) of evaluation of this end point: At treatment day and within 6 months from study approval.

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Countries

Denmark

Contacts

Public ContactDepartment of Dermatology

Bispebjerg Hospital

katrine.togsverd-bo@regionh.dk004538635000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026