HealthyPhase 1NCT04361136
Clinical Trial to Evaluate Light-induced 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
This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after 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
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 23 Apr 2020to 30 May 2020
- 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 history of or presence of cancerous or precancerous skin lesions.
- 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.
- Known disease that can be induced by ultraviolet (UV) light.
- Use of any topical or systemic medication which could interfere with the trial objective within 2 weeks before randomisation until end of trial.
- Use of drugs which might cause photobiologic or phototoxic reactions within 4 weeks before randomisation until end of trial.
- Foreseeable intensive UV light exposure (solar or artificial) to test fields within 4 weeks before randomisation until end of trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Phototoxic Potential of Delgocitinib Cream After Single Topical Occlusive Application on Healthy Skin
This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after light exposure in people with healthy skin.
- 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
Also called LEO 124249 cream vehicle
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 1 mg/g | Experimental | Single topical occlusive administration Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 3 mg/g | Experimental | Single topical occlusive administration Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 8 mg/g | Experimental | Single topical occlusive administration Receives: Drug: Delgocitinib cream |
| Delgocitinib cream 20 mg/g | Experimental | Single topical occlusive administration Receives: Drug: Delgocitinib cream |
| Delgocitinib cream vehicle | Placebo comparator | Single topical occlusive administration Receives: Drug: Delgocitinib cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive skin reaction at 24 hours or 48 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 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 48 hours after irradiation
Secondary outcomes (2)
Positive skin reaction at 24 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 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: 24 hours after irradiation
Positive skin reaction at 48 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 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: 48 hours after irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start23 Apr 2020
- Primary completion30 May 2020
- Study completion30 May 2020
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
- Parallel groups
- Model description
- All subjects will receive all treatments with treatments randomised over test fields.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361136
- Sponsor's protocol ID
- LP0133-1408
- Other IDs
- 2019-000705-67, 2019
- Status last verified
- Oct 2020
- First submitted
- 22 Apr 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- 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 Phototoxic Potential of Delgocitinib Cream After Single Topical Occlusive Application on Healthy Skin
- ClinicalTrials.gov ID
- NCT04361136
- Acronym / sponsor ID
- LP0133-1408
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 24 Apr 2020 (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.
This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after light exposure in people with healthy skin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- All subjects will receive all treatments with treatments randomised over test fields.
| Arm | Type | Receives |
|---|---|---|
| Delgocitinib cream 1 mg/g | Experimental | Drug: Delgocitinib creamSingle topical occlusive administration |
| Delgocitinib cream 3 mg/g | Experimental | Drug: Delgocitinib creamSingle topical occlusive administration |
| Delgocitinib cream 8 mg/g | Experimental | Drug: Delgocitinib creamSingle topical occlusive administration |
| Delgocitinib cream 20 mg/g | Experimental | Drug: Delgocitinib creamSingle topical occlusive administration |
| Delgocitinib cream vehicle | Placebo comparator | Drug: Delgocitinib cream vehicleSingle 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 history of or presence of cancerous or precancerous skin lesions.
- 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.
- Known disease that can be induced by ultraviolet (UV) light.
- Use of any topical or systemic medication which could interfere with the trial objective within 2 weeks before randomisation until 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 1 mg/g, Delgocitinib cream 20 mg/g, Delgocitinib cream 3 mg/g, Delgocitinib cream 8 mg/g |
| Delgocitinib cream vehicleAlso: LEO 124249 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 24 hours or 48 hours after irradiation
Time frame: Up to 48 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 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
2 secondary outcomes
Positive skin reaction at 24 hours after irradiation
Time frame: 24 hours after irradiation
Positive skin reaction at 48 hours after irradiation
Time frame: 48 hours after irradiation
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.
Medical Expert study director
LEO Pharma
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 24 hours or 48 hours after irradiation (time frame: Up to 48 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; AzTrials last refreshed its copy on 6 Nov 2026.