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Skin Microbiome and Polymorphic Light Eruption (PLE_microbio)

Primary Purpose

Polymorphic Light Eruption

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polymorphic Light Eruption

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Dermatology, Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Polymorphic light eruption patients

Healthy subjects

Arm Description

PLE patients subjected to MED testing and photoprovocation

Normal healthy subjects

Outcomes

Primary Outcome Measures

Quantification of PLE
determined by PLE score (range, 0-12) of photo provocation results (0 best, 12 worst)
Quantification of erythema score (range, 0-4)
determined by visual and spectroscopic erythema score
Quantification of pigmentation (range, 0-4)
determined by visual and spectroscopic erythema score

Secondary Outcome Measures

Measurement of multiple cytokines (panel of 96 cytokines)
determined by transcriptomics
Assessment of multiple microbiomes of the skin (quantity and variety)
determined by metagenomics
Measurement of quantity and quality of multiple Antimicrobial peptides (AMP)
determined by proteomics
Measurement of concentration of cis/trans-urocanic acid
determined by high pressure liquid chromotography (HPLC)
Quantification of cellular skin infiltration (T cells, granulocytes and macrophages)
determined by hematoxylin and eosin (H/E) and immunohistochemical stainings

Full Information

First Posted
June 14, 2021
Last Updated
July 22, 2021
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04985526
Brief Title
Skin Microbiome and Polymorphic Light Eruption
Acronym
PLE_microbio
Official Title
The Significance of the Skin Microbiome in the Pathophysiology of Polymorphic Light Eruption
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymorphic Light Eruption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polymorphic light eruption patients
Arm Type
Experimental
Arm Description
PLE patients subjected to MED testing and photoprovocation
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
Normal healthy subjects
Intervention Type
Other
Intervention Name(s)
Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)
Intervention Description
Administering Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) or 0,9% sodium chloride (as control agent) to the skin
Primary Outcome Measure Information:
Title
Quantification of PLE
Description
determined by PLE score (range, 0-12) of photo provocation results (0 best, 12 worst)
Time Frame
1 week
Title
Quantification of erythema score (range, 0-4)
Description
determined by visual and spectroscopic erythema score
Time Frame
1 week
Title
Quantification of pigmentation (range, 0-4)
Description
determined by visual and spectroscopic erythema score
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Measurement of multiple cytokines (panel of 96 cytokines)
Description
determined by transcriptomics
Time Frame
1 week
Title
Assessment of multiple microbiomes of the skin (quantity and variety)
Description
determined by metagenomics
Time Frame
1 week
Title
Measurement of quantity and quality of multiple Antimicrobial peptides (AMP)
Description
determined by proteomics
Time Frame
1 week
Title
Measurement of concentration of cis/trans-urocanic acid
Description
determined by high pressure liquid chromotography (HPLC)
Time Frame
1 week
Title
Quantification of cellular skin infiltration (T cells, granulocytes and macrophages)
Description
determined by hematoxylin and eosin (H/E) and immunohistochemical stainings
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Wolf, MD
Phone
0043 316 385
Ext
80315
Email
peter.wolf@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Maximilian Zarfl
Phone
00 43 660 6682953‬
Email
maximilian.zarfl@stud.medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wolf, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Wolf
Phone
031638580315
Email
peter.wolf@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Maximilian Zarfl
Phone
00 43 660 6682953‬
Email
maximilian.zarfl@stud.medunigraz.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Skin Microbiome and Polymorphic Light Eruption

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