CClinicalTrials.gg
Sign In
CompletedNCT01768013Updated Mar 12, 2025Results posted

The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris

A Phase 1/2 interventional study of LEO 90105 in Psoriasis Vulgaris, sponsored by LEO Pharma. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by LEO Pharma · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.

02

Conditions studied

  • Psoriasis Vulgaris

Browse trials for

03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 13 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Japanese subjects having understood and signed a written informed consent form prior to any study related procedures being carried out (including activities related to the wash out period)
  • 20 years of age or above.
  • Either sex.
  • Clinical diagnosis of psoriasis vulgaris amenable to topical treatment involving arms and/or trunk and/or legs.
  • Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds) of not more than 30% body surface area (BSA)
  • An Investigator's global assessment of disease severity (IGA) on area(s) to be treated of moderate, severe or very severe and a m-PASI score of ≥12.
  • Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control, as judged by the (sub)investigator, during the study. The contraceptive method should have started an adequate amount of time before the pregnancy test, which is dependent on the particular method used and as judged by the (sub)investigator, and must continue for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alter-native medical cause) or surgically sterile (tubal ligation /section, hysterectomy or bilateral ovariectomy).

Exclusion criteria

Exclusion Criteria:

  • Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to Visit 1:
  • etanercept, adalimumab, infliximab -3 months.
  • ustekinumab - 4 months
  • other products - within 3 months/5 half-lives (whichever is longer).
  • Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immu-nosuppressants such as ciclosporin and methotrexate) within 4 weeks prior to Visit 1 (use of inhaled and nasal corticosteroids is allowed, use of systemic antihistamines is allowed).
  • Topical treatment of scalp psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or very potent WHO group IV corticosteroids within 2 weeks prior to Visit 1.
  • PUVA therapy, UVB therapy or UVA therapy within 4 weeks prior to Visit 1.
  • Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV corticosteroids within 2 weeks prior to Visit 1.
  • Topical treatment of psoriasis on area(s) to be treated with study medication within the 2-week period prior to Visit 1. (Use of emollients is allowed during this 2- week period, but not during the study.)
  • Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs, lithium and ACE inhibitors) during the study.
  • Topical treatment of conditions other than psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV corti-costeroids within 2 weeks prior to Visit 1.
  • Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.
  • Clinical signs or symptoms of Cushing's disease or Addison's disease
  • Patients with any of the following disorders (a) or symptoms (b) present on the area(s) to be treated with study medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, ichthyosis, acne rosacea, ulcers, burns, frostbite, wounds, or (b) fragility of skin veins.
  • Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris.
  • Planned excessive exposure of treated areas(s) to either natural or artificial sunlight (including tanning boths, sun lamps, etc) during the study.
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia (subjects with results for albumin-corrected serum calcium above the reference range from the sample taken at the Washout/Screening Visit.
  • Severe renal insufficiency, severe hepatic disorders or severe heart disease.
  • Known or suspected hypersensitivity to components of the investigational products.
  • Current participation in any other interventional clinical study
  • Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to Visit 1 or longer, if the class of substance re-quires a longer washout as defined above (e.g. biological treatments).
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding
  • Patients suspected of being unable to comply with the study protocol, e.g. due to alcoholism, drug dependence or psychotic state.
  • Previous enrollment in this study.
  • Hospitalised patients.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    LEO 90105 Ointment

    Drug: LEO 90105

Interventions

  • DrugLEO 90105

    Once daily for four weeks

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic: Cmax of Betamethasone Dipropionate

    The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.

    Time frame: Day 1

  2. Pharmacokinetic: Cmax of Betamethasone Dipropionate

    The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined

    Time frame: Day 7

  3. Pharmacokinetic: Cmax of Betamethasone Dipropionate

    The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined

    Time frame: Day 14

  4. Pharmacokinetic: AUClast of Betamethasone Dipropionate

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

    Time frame: Day 1

  5. Pharmacokinetic: AUClast of Betamethasone Dipropionate

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

    Time frame: Day 7

  6. Pharmacokinetic: AUClast of Betamethasone Dipropionate

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

    Time frame: Day 14

  7. Pharmacokinetic: Cmax of Betamethasone 17-propionate

    The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

    Time frame: Day 1

  8. Pharmacokinetic: Cmax of Betamethasone 17-propionate

    The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

    Time frame: Day 7

  9. Pharmacokinetic: Cmax of Betamethasone 17-propionate

    The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

    Time frame: Day 14

  10. Pharmacokinetic: AUClast of Betamethasone 17-propionate

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

    Time frame: Day 1

  11. Pharmacokinetic: AUClast of Betamethasone 17-propionate

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

    Time frame: Day 7

  12. Pharmacokinetic: AUClast of Betamethasone 17-propionate

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

    Time frame: Day 14

  13. Pharmacokinetic: Cmax of Calcipotriol

    The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

    Time frame: Day 1

  14. Pharmacokinetic: Cmax of Calcipotriol

    The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

    Time frame: Day 7

  15. Pharmacokinetic: Cmax of Calcipotriol

    The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

    Time frame: Day 14

  16. Pharmacokinetic: AUClast of Calcipotriol

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

    Time frame: Day 1

  17. Pharmacokinetic: AUClast of Calcipotriol

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

    Time frame: Day 7

  18. Pharmacokinetic: AUClast of Calcipotriol

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

    Time frame: Day 14

  19. Pharmacokinetic: Cmax of MC1080

    The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

    Time frame: Day 1

  20. Pharmacokinetic: Cmax of MC1080

    The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

    Time frame: Day 7

  21. Pharmacokinetic: Cmax of MC1080

    The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

    Time frame: Day 14

  22. Pharmacokinetic: AUClast of MC1080

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

    Time frame: Day 1

  23. Pharmacokinetic: AUClast of MC1080.

    To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

    Time frame: Day 7

  24. Pharmacokinetic: AUClast of MC1080.

    The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

    Time frame: Day 14

Secondary outcomes

  1. Efficacy: Percentage Change in m-PASI From Baseline to Day 28

    Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease. The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified.

    Time frame: Baseline to Day 28

  2. Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.

    Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28. Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.

    Time frame: Day 28

07

Results

Posted Dec 30, 2013

Participant flow

First subject first visit: 09-Jul-2012 Last subject last visit: 30-Oct-2012

Participant flow — Overall Study
MilestoneLEO 90105 Ointment
Started13
Completed13
Not completed0

Outcome measures

PrimaryPharmacokinetic: Cmax of Betamethasone Dipropionate

The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.

Time frame:
Day 1
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Betamethasone Dipropionate
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of Betamethasone DipropionateNA ± NA
PrimaryPharmacokinetic: Cmax of Betamethasone Dipropionate

The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined

Time frame:
Day 7
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Betamethasone Dipropionate
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of Betamethasone DipropionateNA ± NA
PrimaryPharmacokinetic: Cmax of Betamethasone Dipropionate

The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined

Time frame:
Day 14
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Betamethasone Dipropionate
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of Betamethasone DipropionateNA ± NA
PrimaryPharmacokinetic: AUClast of Betamethasone Dipropionate

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

Time frame:
Day 1
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Betamethasone Dipropionate
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of Betamethasone DipropionateNA ± NA
PrimaryPharmacokinetic: AUClast of Betamethasone Dipropionate

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

Time frame:
Day 7
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Betamethasone Dipropionate
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of Betamethasone DipropionateNA ± NA
PrimaryPharmacokinetic: AUClast of Betamethasone Dipropionate

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined

Time frame:
Day 14
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Betamethasone Dipropionate
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of Betamethasone DipropionateNA ± NA
PrimaryPharmacokinetic: Cmax of Betamethasone 17-propionate

The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

Time frame:
Day 1
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Betamethasone 17-propionate
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of Betamethasone 17-propionate218.8 ± 351.01
PrimaryPharmacokinetic: Cmax of Betamethasone 17-propionate

The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

Time frame:
Day 7
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Betamethasone 17-propionate
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of Betamethasone 17-propionate101.5 ± 77.551
PrimaryPharmacokinetic: Cmax of Betamethasone 17-propionate

The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined

Time frame:
Day 14
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Betamethasone 17-propionate
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of Betamethasone 17-propionate116 ± 64.826
PrimaryPharmacokinetic: AUClast of Betamethasone 17-propionate

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

Time frame:
Day 1
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Betamethasone 17-propionate
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of Betamethasone 17-propionate1036.7 ± 1885.01
PrimaryPharmacokinetic: AUClast of Betamethasone 17-propionate

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

Time frame:
Day 7
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Betamethasone 17-propionate
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of Betamethasone 17-propionate570.92 ± 517.107
PrimaryPharmacokinetic: AUClast of Betamethasone 17-propionate

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined

Time frame:
Day 14
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Betamethasone 17-propionate
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of Betamethasone 17-propionate634.65 ± 467.426
PrimaryPharmacokinetic: Cmax of Calcipotriol

The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

Time frame:
Day 1
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Calcipotriol
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of Calcipotriol107.6 ± NA
PrimaryPharmacokinetic: Cmax of Calcipotriol

The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

Time frame:
Day 7
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Calcipotriol
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of CalcipotriolNA ± NA
PrimaryPharmacokinetic: Cmax of Calcipotriol

The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined

Time frame:
Day 14
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of Calcipotriol
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of CalcipotriolNA ± NA
PrimaryPharmacokinetic: AUClast of Calcipotriol

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

Time frame:
Day 1
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Calcipotriol
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of Calcipotriol169.6 ± NA
PrimaryPharmacokinetic: AUClast of Calcipotriol

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

Time frame:
Day 7
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Calcipotriol
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of CalcipotriolNA ± NA
PrimaryPharmacokinetic: AUClast of Calcipotriol

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined

Time frame:
Day 14
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of Calcipotriol
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of CalcipotriolNA ± NA
PrimaryPharmacokinetic: Cmax of MC1080

The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

Time frame:
Day 1
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of MC1080
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of MC108095.35 ± NA
PrimaryPharmacokinetic: Cmax of MC1080

The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

Time frame:
Day 7
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of MC1080
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of MC108057.57 ± 36.218
PrimaryPharmacokinetic: Cmax of MC1080

The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined

Time frame:
Day 14
Reported as:
Mean · pg/mL
Pharmacokinetic: Cmax of MC1080
pg/mLLEO 90105 Ointment
Pharmacokinetic: Cmax of MC1080NA ± NA
PrimaryPharmacokinetic: AUClast of MC1080

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

Time frame:
Day 1
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of MC1080
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of MC1080430.9 ± NA
PrimaryPharmacokinetic: AUClast of MC1080.

To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

Time frame:
Day 7
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of MC1080.
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of MC1080.221.2 ± 175.16
PrimaryPharmacokinetic: AUClast of MC1080.

The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined

Time frame:
Day 14
Reported as:
Mean · h*pg/mL
Pharmacokinetic: AUClast of MC1080.
h*pg/mLLEO 90105 Ointment
Pharmacokinetic: AUClast of MC1080.NA ± NA
SecondaryEfficacy: Percentage Change in m-PASI From Baseline to Day 28

Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease. The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified.

Time frame:
Baseline to Day 28
Reported as:
Mean · percentage of change
Efficacy: Percentage Change in m-PASI From Baseline to Day 28
percentage of changeLEO 90105 Ointment
Efficacy: Percentage Change in m-PASI From Baseline to Day 28-72.4 ± 24.5
SecondaryEfficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.

Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28. Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.

Time frame:
Day 28
Reported as:
Number · participants
Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.
participantsLEO 90105 Ointment
Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.6

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LEO 90105 Ointment—0/13 (0%)4/13 (30.8%)
Most frequent other events
Most frequent other events
EventLEO 90105 Ointment
Abdominal discomfortGastrointestinal disorders1/13
FolliculitisInfections and infestations1/13
Skin injuryInjury, poisoning and procedural complications1/13
ArthralgiaMusculoskeletal and connective tissue disorders1/13
Orthostatic hypotensionVascular disorders1/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)LEO 90105 Ointment
<=18 years0
Between 18 and 65 years8
>=65 years5
Age, Continuous
Age, Continuous(years)LEO 90105 Ointment
Mean54.2 ± 15.4
Sex: Female, Male
Sex: Female, Male(Participants)LEO 90105 Ointment
Female3
Male10
Region of Enrollment
Region of Enrollment(participants)LEO 90105 Ointment
Japan13
08

Study locations

1 site
  • Tokyo, Japan
09

References and documents

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01768013
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
Jan 15, 2013
Start date
Jul 2012
Primary completion
Oct 2012
Completion
Oct 2012
Results posted
Dec 30, 2013
Last update
Mar 12, 2025
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Psoriasis→

Other studies from this sponsor

LEO Pharma

Start the discussion