HealthyPhase 1NCT04807751
Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream
A Phase 1 study testing Delgocitinib cream in people with Healthy, run by LEO Pharma at 1 site in Germany.
Trial summary
Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Delgocitinib cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2021to 30 Jul 2021
- Phase
- Phase 1
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18-64 years (inclusive).
- Fitzpatrick skin type of I, II, or III.
Who cannot join
- Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes, or dense body hair in the range of the test fields.
- Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction.
- Any history of or presence of cancerous or precancerous skin lesions in general including melanoma, lentigo maligna, basal cell carcinoma, dysplastic naevi or actinic keratoses.
- History of or active or both photo-induced or photo-aggravated disease (e.g. cutaneous or lupus erythematodes, polymorphic light eruptions).
- Use of any topical or systemic medication that could interfere with the trial objective within 2 weeks before randomisation until subject's end of trial.
- Use of drugs that might cause photosensitising or phototoxic reactions within 4 weeks before randomisation until subject's end of trial.
- Foreseeable intensive UV-light exposure to test fields within 4 weeks before randomisation until subject's end of trial (solar or artificial).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Photoallergic Potential of Delgocitinib Cream 20 mg/g After Topical Occlusive Application in Subjects With Healthy Skin
Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin.
Read the detailed description
This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject comparison phase 1 trial in Germany.
The trial consists of a screening phase, an induction phase, a rest phase, and a challenge phase. There will be 2 columns of test fields on each participant's back with the 3 treatments in either column for a total of 6 treatments. One column of test fields will be irradiated and the other will not be irradiated. All participants will be exposed to UV-light on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be irradiated.
- Conditions
- Healthy
- Being tested
- Delgocitinib cream, Delgocitinib cream vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delgocitinib creamDrug
Also called LEO 124249 cream
Cream for topical application
Delgocitinib cream vehicleDrug
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | topical occlusive administration Receives: Drug: Delgocitinib cream |
| Delgocitinib cream vehicle | Placebo comparator | topical occlusive administration Receives: Drug: Delgocitinib cream vehicle |
| Untreated skin | No intervention | topical occlusive administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive skin reaction at 72 hours after irradiation
A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field.
The evaluation of skin reaction at the end of the challenge phase performed using the following scale:
- 0 negative
- 1 equivocal
- 2 positive. A positive score indicates presence of a UV-light-induced allergic skin reaction.
Measured: Up to 72 hours after irradiation
Secondary outcomes (3)
Number of adverse events from baseline to 14 days after subject's end of trial
Treatment-emergent adverse event
Measured: From baseline to 14 days after subject's end of trial (Day 5 of challenge phase, or if applicable Day 5 of re-challenge phase.
Skin reaction score after irradiation during induction phase
A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field.
The grading for the skin reaction score will be performed according to the following 5-point scale:
- 0 No reaction
- 1 Erythema
- 2 Erythema with dermal infiltrate
- 3 Erythema with papulovesicles
- 4 Erythema with blisters, erosions
Measured: up to Day 22
Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6).
A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field.
The grading for the skin reaction score will be performed according to the following 5-point scale:
- 0 No reaction
- 1 Erythema
- 2 Erythema with dermal infiltrate
- 3 Erythema with papulovesicles
- 4 Erythema with blisters, erosions
Measured: up to Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start25 Mar 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All subjects will receive all treatments with treatments randomised over test fields.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807751
- Sponsor's protocol ID
- LP0133-1411
- Other IDs
- 2020-003090-22
- Status last verified
- Apr 2021
- First submitted
- 18 Mar 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Photoallergic Potential of Delgocitinib Cream 20 mg/g After Topical Occlusive Application in Subjects With Healthy Skin
- ClinicalTrials.gov ID
- NCT04807751
- Acronym / sponsor ID
- LP0133-1411
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 19 Mar 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.
Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin.
Detailed description
This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject comparison phase 1 trial in Germany.
The trial consists of a screening phase, an induction phase, a rest phase, and a challenge phase. There will be 2 columns of test fields on each participant's back with the 3 treatments in either column for a total of 6 treatments. One column of test fields will be irradiated and the other will not be irradiated. All participants will be exposed to UV-light on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be irradiated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All subjects will receive all treatments with treatments randomised over test fields.
| Arm | Type | Receives |
|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | Drug: Delgocitinib creamtopical occlusive administration |
| Delgocitinib cream vehicle | Placebo comparator | Drug: Delgocitinib cream vehicletopical occlusive administration |
| Untreated skin | No intervention | –topical occlusive administration |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects aged 18-64 years (inclusive).
- Fitzpatrick skin type of I, II, or III.
Key exclusion criteria (7 listed)
- Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes, or dense body hair in the range of the test fields.
- Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction.
- Any history of or presence of cancerous or precancerous skin lesions in general including melanoma, lentigo maligna, basal cell carcinoma, dysplastic naevi or actinic keratoses.
- History of or active or both photo-induced or photo-aggravated disease (e.g. cutaneous or lupus erythematodes, polymorphic light eruptions).
- Use of any topical or systemic medication that could interfere with the trial objective within 2 weeks before randomisation until subject's end of trial.
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 |
|---|---|---|
| Delgocitinib creamAlso: LEO 124249 creamCream for topical application | Drug | Delgocitinib cream 20 mg/g |
| Delgocitinib cream vehicleThe cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. | Drug | Delgocitinib cream vehicle |
Primary outcome
Positive skin reaction at 72 hours after irradiation
Time frame: Up to 72 hours after irradiation
A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The evaluation of skin reaction at the end of the challenge phase performed using the following scale: * 0 negative * 1 equivocal * 2 positive. A positive score indicates presence of a UV-light-induced allergic skin reaction.
3 secondary outcomes
Number of adverse events from baseline to 14 days after subject's end of trial
Time frame: From baseline to 14 days after subject's end of trial (Day 5 of challenge phase, or if applicable Day 5 of re-challenge phase.
Skin reaction score after irradiation during induction phase
Time frame: up to Day 22
Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6).
Time frame: up to Day 40
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Delgocitinib cream in people with Healthy, run by LEO Pharma at 1 site in Germany.
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 7 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 28 Apr 2026. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Positive skin reaction at 72 hours after irradiation (time frame: Up to 72 hours after irradiation). 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 28 Apr 2026.