Polymorphic Light EruptionNCT00549588
Sunscreen and After-sun-lotion Protection in Polymorphic Light Eruption
A study testing After-sun-lotion with DNA repair enzymes, SPF30 sunscreen and Intervention: none (only UV) in people with Polymorphic Light Eruption, run by Medical University of Graz at 1 site in Austria.
Trial summary
Polymorphic light eruption (PLE) is a common photodermatosis characterized by the appearance of itching, erythema, papules or vesicles on sun-exposed skin. Though etiology is unclear it is hypothesized that it is an abnormal immune response to autologous antigens generated by ultraviolet radiation (UVR). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Polymorphic Light Eruption
- What is being tested?
- After-sun-lotion with DNA repair enzymes, SPF30 sunscreen and Intervention: none (only UV)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2004to Aug 2006
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PLE either by typical history and/or typical histology of lesions and/or positive phototesting results
Who cannot join
- Presence of or history of malignant skin tumors
- Dysplastic melanocytic nevus syndrome
- Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
- Psychiatric disorders
- Systemic treatment with steroids and/or other immunosuppressive drugs
Show all 10Show fewer
- Pregnancy or lactation
- Antinuclear antibodies
- UV exposure in test fields within 8 weeks before study start
- General poor health status
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Dermatology
Graz, A-8036
About this study
Official title: The Efficacy of a Sunscreen With SPF30 and a After-sun-lotion in the Prevention of Polymorphic Light Eruption
Polymorphic light eruption (PLE) is a common photodermatosis characterized by the appearance of itching, erythema, papules or vesicles on sun-exposed skin. Though etiology is unclear it is hypothesized that it is an abnormal immune response to autologous antigens generated by ultraviolet radiation (UVR). This randomized, double blinded left-right body side experimental comparison study was designed to assess the preventive effect of a sunscreen and topical DNA repair enzyme-containing after-sun lotion in PLE.
Read the detailed description
A SPF 30 sunscreen (containing chemical and physical UV filters), an after-sun lotion containing liposomal encapsulated micrococcus luteus lysate with endonuclease activity and photolyase (active AS), and an after-sun placebo formulation (containing no DNA repair enzymes) (placebo AS) has been used in this study. Fourteen PLE patients were enrolled. On day 1, the individual minimal erythema dose (MED) was assessed on patients' buttock skin by exposure to a test ladder of solar-simulated UVR (xenon arc source, Oriel Corp. Darmstadt, Germany). From day 2 to 5, 0.75 individual MED exposures (increased by 0 to 25% per exposure, depending on the erythema response to a preceding dose) were given to a total of four 5-by-5 cm skin test fields on symmetrically located, individual PLE predilection sites on the trunk or extremities. The test fields were treated in randomized and double-blinded fashion either with SPF30 sunscreen 20 min before UVR exposure, active AS or placebo AS (all creams at a concentration of 2mg/cm2) immediately after UVR exposure, or left untreated. Sixty minutes after UVR exposure all test areas were treated with visible light (400 to 450nm, 5J/cm2) to activate the light dependent photolyase DNA repair mechanism. The photo test procedure led to the appearance of PLE symptoms in unprotected test fields of 12/14 (86%) patients, active AS-treated test fields of 6/14 (43%) patients (p<0.05), placebo AS-treated test fields of 10/14 (71%) patients (p, ns), and no (0%) sunscreen-protected test fields of any patient (p<0.0001 vs. unprotected test fields, Fisher exact test). These results provide evidence that i) DNA damage is a trigger of PLE, ii) increasing DNA repair can prevent induction of PLE symptoms, and iii) the use of sun care preparations containing DNA repair enzymes may be clinically useful for PLE patients.
- Conditions
- Polymorphic Light Eruption
- Being tested
- After-sun-lotion with DNA repair enzymes, SPF30 sunscreen, Placebo after-sun-lotion, Intervention: none (only UV)
- Keywords
- Polymorphic light eruption, UV radiation, photoprotection, sunscreen, DNA repair enzymes, after-sun-lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After-sun-lotion with DNA repair enzymesOther
Also called Proprietary after-sun lotion (Ateia Inc.)
2 mg/cm2 immediately after UV exposure
SPF30 sunscreenOther
Also called SPF30 sunscreen (Ateia Inc.)
2 mg/cm2 2o min before UV exposure
Placebo after-sun-lotionOther
Also called Proprietary after sun lotion vehicle (Ateia Inc.)
2mg/cm2 immediately after UV exposure
Intervention: none (only UV)Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of symptoms of polymorphic light eruption
Measured: Prospective
Secondary outcomes (5)
Pruritus
Measured: Prospective
Skin infiltration
Measured: prospective
Area affected
Measured: prospective
Erythema
Measured: prospective
Tanning
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startFeb 2004
- Primary completionJun 2004
- Study completionAug 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Peter Wolf, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549588
- Sponsor's protocol ID
- 14-058 ex 03/04
- Status last verified
- Sep 2009
- First submitted
- 24 Oct 2007
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Sunscreen With SPF30 and a After-sun-lotion in the Prevention of Polymorphic Light Eruption
- ClinicalTrials.gov ID
- NCT00549588
- Acronym / sponsor ID
- 14-058 ex 03/04
- Conditions
- Polymorphic Light Eruption
- Keywords
- Polymorphic light eruption, UV radiation, photoprotection, sunscreen, DNA repair enzymes, after-sun-lotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 26 Oct 2007 (estimated)
- 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 a common photodermatosis characterized by the appearance of itching, erythema, papules or vesicles on sun-exposed skin. Though etiology is unclear it is hypothesized that it is an abnormal immune response to autologous antigens generated by ultraviolet radiation (UVR). This randomized, double blinded left-right body side experimental comparison study was designed to assess the preventive effect of a sunscreen and topical DNA repair enzyme-containing after-sun lotion in PLE.
Detailed description
A SPF 30 sunscreen (containing chemical and physical UV filters), an after-sun lotion containing liposomal encapsulated micrococcus luteus lysate with endonuclease activity and photolyase (active AS), and an after-sun placebo formulation (containing no DNA repair enzymes) (placebo AS) has been used in this study. Fourteen PLE patients were enrolled. On day 1, the individual minimal erythema dose (MED) was assessed on patients' buttock skin by exposure to a test ladder of solar-simulated UVR (xenon arc source, Oriel Corp. Darmstadt, Germany). From day 2 to 5, 0.75 individual MED exposures (increased by 0 to 25% per exposure, depending on the erythema response to a preceding dose) were given to a total of four 5-by-5 cm skin test fields on symmetrically located, individual PLE predilection sites on the trunk or extremities. The test fields were treated in randomized and double-blinded fashion either with SPF30 sunscreen 20 min before UVR exposure, active AS or placebo AS (all creams at a concentration of 2mg/cm2) immediately after UVR exposure, or left untreated. Sixty minutes after UVR exposure all test areas were treated with visible light (400 to 450nm, 5J/cm2) to activate the light dependent photolyase DNA repair mechanism. The photo test procedure led to the appearance of PLE symptoms in unprotected test fields of 12/14 (86%) patients, active AS-treated test fields of 6/14 (43%) patients (p<0.05), placebo AS-treated test fields of 10/14 (71%) patients (p, ns), and no (0%) sunscreen-protected test fields of any patient (p<0.0001 vs. unprotected test fields, Fisher exact test). These results provide evidence that i) DNA damage is a trigger of PLE, ii) increasing DNA repair can prevent induction of PLE symptoms, and iii) the use of sun care preparations containing DNA repair enzymes may be clinically useful for PLE patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of PLE either by typical history and/or typical histology of lesions and/or positive phototesting results
Key exclusion criteria (10 listed)
- Presence of or history of malignant skin tumors
- Dysplastic melanocytic nevus syndrome
- Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
- Psychiatric disorders
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 |
|---|---|---|
| After-sun-lotion with DNA repair enzymesAlso: Proprietary after-sun lotion (Ateia Inc.)2 mg/cm2 immediately after UV exposure | Other | – |
| SPF30 sunscreenAlso: SPF30 sunscreen (Ateia Inc.)2 mg/cm2 2o min before UV exposure | Other | – |
| Placebo after-sun-lotionAlso: Proprietary after sun lotion vehicle (Ateia Inc.)2mg/cm2 immediately after UV exposure | Other | – |
| Intervention: none (only UV) | Other | – |
Primary outcome
Occurrence of symptoms of polymorphic light eruption
Time frame: Prospective
5 secondary outcomes
Pruritus
Time frame: Prospective
Skin infiltration
Time frame: prospective
Area affected
Time frame: prospective
Erythema
Time frame: prospective
Tanning
Time frame: Prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
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 After-sun-lotion with DNA repair enzymes, SPF30 sunscreen and Intervention: none (only UV) 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 30 Sep 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of symptoms of polymorphic light eruption (time frame: Prospective). 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 30 Sep 2009.