NCT04985526

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

June 14, 2021

Last Update Submit

July 22, 2021

Conditions

Polymorphic Light Eruption

Outcome Measures

Primary Outcomes (3)

  • Quantification of PLE

    determined by PLE score (range, 0-12) of photo provocation results (0 best, 12 worst)

    1 week

  • Quantification of erythema score (range, 0-4)

    determined by visual and spectroscopic erythema score

    1 week

  • Quantification of pigmentation (range, 0-4)

    determined by visual and spectroscopic erythema score

    1 week

Secondary Outcomes (5)

  • Measurement of multiple cytokines (panel of 96 cytokines)

    1 week

  • Assessment of multiple microbiomes of the skin (quantity and variety)

    1 week

  • Measurement of quantity and quality of multiple Antimicrobial peptides (AMP)

    1 week

  • Measurement of concentration of cis/trans-urocanic acid

    1 week

  • Quantification of cellular skin infiltration (T cells, granulocytes and macrophages)

    1 week

Study Arms (2)

Polymorphic light eruption patients

EXPERIMENTAL

PLE patients subjected to MED testing and photoprovocation

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

Healthy subjects

OTHER

Normal healthy subjects

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

Interventions

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

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

Healthy subjectsPolymorphic light eruption patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Medical University of Graz

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Interventions

octenidine1-Propanol2-Propanol

Intervention Hierarchy (Ancestors)

PropanolsAlcoholsOrganic Chemicals

Study Officials

  • Peter Wolf, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Wolf, MD

CONTACT

0043 316 385peter.wolf@medunigraz.at

Maximilian Zarfl

CONTACT

00 43 660 6682953‬maximilian.zarfl@stud.medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

August 2, 2021

Study Start

May 7, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

AU(1)