Skin Microbiome and Polymorphic Light Eruption

NCT ID: NCT04985526

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2023-06-30

Brief Summary

Polymorphic light eruption (PLE) is the most common form among UV-inducible disorders with a prevalence of approximately 11-21% worldwide and a clear predisposition of women. Usually, within several hours after an intense UV exposure, most likely in spring or early summer, the formation of itchy skin lesions particularly at the upper arms and V-neck and neck is distinctive for PLE. It has been suggested that the development of a potential photo-induced antigen may initiate a delayed-type hypersensitivity reaction in PLE (causing the skin rash) and the microbiota of the skin may be involved. We thus hypothesized that eliminating the microbiota of the skin by disinfection may affect the formation of PLE. The concept of this study covers a combined interindividual and intraindividual half-body comparison of the skin reactions of disinfected and contralateral non-disinfected areas upon UV exposure in PLE patients and healthy subjects.

Detailed Description

UV-induced erythema and pigmentation is quantified by visual scoring and reflectance spectroscopy to determine the minimum erythema dose (MED) exploring the fields of an UV test ladder on the dorsal skin of the study subjects.

Investigations after determining the MED and consecutive photo provocations on 4 subsequent days (PLE group only) using solar simulated UV radiation with slight dose increments include a half-body site comparison of test areas located on the back of the subjects in a randomized, double blinded manner. The microbiota of a respective test area is removed by the disinfection with Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) whereas a control site remains non-disinfected (sham-treated with physiologic sodium chloride solution).

The PLE related symptoms are evaluated by a validated PLE score, which is composed as follows:

Affected skin area (AA) [range, 0-4] + skin infiltration (SI) [range, 0-4] + 0.4 pruritus (P) [range, 0-10]; ([total range 0-12].

As additional procedures, tape strips and skin swabs are taken immediately after UV exposures. The material is used for shotgun metagenomic sequencing of microbes and further analysis such as quantitative measures of antimicrobial peptides and urocanic acid levels. Furthermore, suction blisters are produced after MED testing and the last day of photo provocation [Time Frame: At day 3 and 6] to profile the inflammatory milieu of the skin by transcriptomics. The epidermal blister roof is used together with optional skin biopsies (PLE patients only) for various investigations, including H/E and immunohistochemical stainings and messenger ribonucleic acid (mRNA) analysis.

Conditions

Polymorphic Light Eruption

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Polymorphic light eruption patients

PLE patients subjected to MED testing and photoprovocation

Group Type: EXPERIMENTAL

Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)

Intervention Type: OTHER

Administering Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) or 0,9% sodium chloride (as control agent) to the skin

Healthy subjects

Normal healthy subjects

Group Type: OTHER

Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)

Intervention Type: OTHER

Administering Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) or 0,9% sodium chloride (as control agent) to the skin

Interventions

Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)

Administering Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) or 0,9% sodium chloride (as control agent) to the skin

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation test
• Healthy subjects

Exclusion Criteria

• Presence or history of malignant skin tumors; dysplastic melanocytic nevus syndrome
• Photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma
• pigmentosum, basal cell nevus syndrome
• Autoimmune disorders such as lupus erythematosus or dermatomyositis
• Antinuclear antibodies titer over 1:160 within 12 months prior study
• Systemic treatment of steroids and/or immunosuppressive drugs within 4 weeks prior the study start
• Systemic treatment of antibiotics within the last 6 weeks prior study
• Local treatment of anti-microbial treatment in the test field area within the last 6 weeks prior the study
• Systemic treatment of medications/drugs/ that could affect inflammatory responses within 2 weeks prior study
• Allergy on tape strips and/or adhesive material
• Psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Department of Dermatology, Medical University of Graz

Graz, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Peter Wolf, MD

Role: CONTACT

peter.wolf@medunigraz.at

0043 316 385 ext. 80315

Maximilian Zarfl

Role: CONTACT

maximilian.zarfl@stud.medunigraz.at

00 43 660 6682953‬

Facility Contacts

Peter Wolf

Role: primary

peter.wolf@medunigraz.at

031638580315

Maximilian Zarfl

Role: backup

maximilian.zarfl@stud.medunigraz.at

00 43 660 6682953‬

Other Identifiers

33-196 ex 20/21

Identifier Type: -

Identifier Source: org_study_id