A Phase 2 interventional study of LEO 43204 in Actinic Keratosis, sponsored by LEO Pharma. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by LEO Pharma · Phase 2, Interventional, and Treatment
The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 189 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
Exclusion Criteria:
Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months
Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
Drug: LEO 43204
Drug: LEO 43204
Drug: LEO 43204
Treatment of actinic keratosis
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
For face/chest, a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following five LSRs: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following four LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3
Time frame: 8 days / From baseline (Day 1) to Day 8
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
Time frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.
Time frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percentage of Participants With Complete Clearance of AKs
Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
Time frame: 8 weeks
| Milestone | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities |
|---|---|---|---|
| Started | 63 | 63 | 63 |
| Completed | 63 | 62 | 62 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 |
For face/chest, a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following five LSRs: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following four LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3
| Participants | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities |
|---|---|---|---|
| Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions) | 9 | 0 | 11 |
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
| percentage of reduction | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities |
|---|---|---|---|
| Week 4 | 81.2 (74.7 to 86.1) | 78.8 (71.6 to 84.1) | 59.0 (50.0 to 66.3) |
| Week 8 | 78.9 (70.9 to 84.7) | 76.3 (66.7 to 83.1) | 69.1 (60.3 to 76.0) |
Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.
| percentage of reduction | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities |
|---|---|---|---|
| Week 4 | 78.7 (38.7 to 92.6) | 58.1 (6.8 to 81.2) | 36.0 (1.3 to 58.5) |
| Week 8 | 68.5 (4.5 to 89.6) | 62.5 (-13.2 to 87.5) | 39.2 (7.9 to 59.9) |
Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
| percentage of participants | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities |
|---|---|---|---|
| Percentage of Participants With Complete Clearance of AKs | 36.5 (24.7 to 49.6) | 39.7 (27.6 to 52.8) | 22.6 (12.9 to 35.0) |
Collected over From baseline to Week 8±7 days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LEO 43204 0.018% Face/Chest | — | 1/63 (1.6%) | 35/63 (55.6%) |
| LEO 43204 0.037% Scalp | — | 0/63 (0%) | 47/63 (74.6%) |
| LEO 43204 0.1% Trunk/Extremities | — | 0/62 (0%) | 43/62 (69.4%) |
| Event | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities |
|---|---|---|---|
| Inguinal herniaGastrointestinal disorders | 1/63 | 0/63 | 0/62 |
| Event | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities |
|---|---|---|---|
| Application site painGeneral disorders | 28/63 | 34/63 | 26/62 |
| Application site pruritusGeneral disorders | 18/63 | 23/63 | 21/62 |
| Periorbital oedemaEye disorders | 2/63 | 3/63 | 2/62 |
| ExcoriationInjury, poisoning and procedural complications | 0/63 | 3/63 | 1/62 |
| Application site discomfortGeneral disorders | 1/63 | 1/63 | 2/62 |
| Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/63 | 0/63 | 2/62 |
| ErythemaSkin and subcutaneous tissue disorders | 0/63 | 0/63 | 2/62 |
| Eyelid oedemaEye disorders | 0/63 | 2/63 | 0/62 |
| NasopharyngitisInfections and infestations | 2/63 | 0/63 | 0/62 |
| Upper respiratory tract infectionInfections and infestations | 0/63 | 2/63 | 0/62 |
The baseline analysis population was based on the full analysis set, defined as all participants who assigned to treatment and who met the inclusion criteria.
| Age, Continuous(years) | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities | Total |
|---|---|---|---|---|
| Mean | 64.0 ± 8.8 | 67.7 ± 9.6 | 66.7 ± 9.6 | 66.2 ± 9.4 |
| Sex: Female, Male(Participants) | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities | Total |
|---|---|---|---|---|
| Female | 23 | 1 | 23 | 47 |
| Male | 40 | 62 | 39 | 141 |
| Region of Enrollment(participants) | LEO 43204 0.018% Face/Chest | LEO 43204 0.037% Scalp | LEO 43204 0.1% Trunk/Extremities | Total |
|---|---|---|---|---|
| United States | 63 | 63 | 62 | 188 |
Plan to share: No
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