Polymorphic Light EruptionPLE_microbioNCT04985526
Skin Microbiome and Polymorphic Light Eruption
A study testing Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) in people with Polymorphic Light Eruption, run by Medical University of Graz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Polymorphic Light Eruption
- What is being tested?
- Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 7 May 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation test
- Healthy subjects
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Dermatology, Medical University of Graz
Graz, Styria, 8036
Peter Wolf, 031638580315, peter.wolf@medunigraz.at
Maximilian Zarfl, 00 43 660 6682953, maximilian.zarfl@stud.medunigraz.at
About this study
Official title: The Significance of the Skin Microbiome in the Pathophysiology of Polymorphic Light Eruption
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.
Read the 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
- Being tested
- Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Polymorphic light eruption patients | Experimental | PLE patients subjected to MED testing and photoprovocation Receives: Other: Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) |
| Healthy subjects | Other | Normal healthy subjects Receives: Other: Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of PLE
determined by PLE score (range, 0-12) of photo provocation results (0 best, 12 worst)
Measured: 1 week
Quantification of erythema score (range, 0-4)
determined by visual and spectroscopic erythema score
Measured: 1 week
Quantification of pigmentation (range, 0-4)
determined by visual and spectroscopic erythema score
Measured: 1 week
Secondary outcomes (5)
Measurement of multiple cytokines (panel of 96 cytokines)
determined by transcriptomics
Measured: 1 week
Assessment of multiple microbiomes of the skin (quantity and variety)
determined by metagenomics
Measured: 1 week
Measurement of quantity and quality of multiple Antimicrobial peptides (AMP)
determined by proteomics
Measured: 1 week
Measurement of concentration of cis/trans-urocanic acid
determined by high pressure liquid chromotography (HPLC)
Measured: 1 week
Quantification of cellular skin infiltration (T cells, granulocytes and macrophages)
determined by hematoxylin and eosin (H/E) and immunohistochemical stainings
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start7 May 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymorphic Light EruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Wolf, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985526
- Sponsor's protocol ID
- 33-196 ex 20/21
- Acronym
- PLE_microbio
- Status last verified
- Jul 2021
- First submitted
- 14 Jun 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of the Skin Microbiome in the Pathophysiology of Polymorphic Light Eruption
- ClinicalTrials.gov ID
- NCT04985526
- Acronym / sponsor ID
- PLE_microbio / 33-196 ex 20/21
- Conditions
- Polymorphic Light Eruption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polymorphic light eruption patients | Experimental | Other: Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)PLE patients subjected to MED testing and photoprovocation |
| Healthy subjects | Other | Other: Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)Normal healthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation test
- Healthy subjects
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Healthy subjects, Polymorphic light eruption patients |
Primary outcome
Quantification of PLE
Time frame: 1 week
determined by PLE score (range, 0-12) of photo provocation results (0 best, 12 worst)
Quantification of erythema score (range, 0-4)
Time frame: 1 week
determined by visual and spectroscopic erythema score
Quantification of pigmentation (range, 0-4)
Time frame: 1 week
determined by visual and spectroscopic erythema score
5 secondary outcomes
Measurement of multiple cytokines (panel of 96 cytokines)
Time frame: 1 week
Assessment of multiple microbiomes of the skin (quantity and variety)
Time frame: 1 week
Measurement of quantity and quality of multiple Antimicrobial peptides (AMP)
Time frame: 1 week
Measurement of concentration of cis/trans-urocanic acid
Time frame: 1 week
Quantification of cellular skin infiltration (T cells, granulocytes and macrophages)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wolf, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) in people with Polymorphic Light Eruption, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Wolf, MD (0043 316 385 ext. 80315, peter.wolf@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of PLE (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.