Trial Outcomes & Findings for Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris (NCT NCT00817219)

Results Overview

The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as "not related".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Week 4

Results posted on

2025-03-12

Participant Flow

The study period was 15 July 2009 (date of first subject's first screening visit) to 05 December 2011 (date of the last subject's last on-treatment visit)

Before starting treatment there was a washout/screening phase lasting for 3 days to 6 weeks, depending on the prior use of excluded treatments.

Participant milestones

Participant milestones
Measure	TACLONEX Ointment TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Age, Continuous	14.6 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as "not related".

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Adverse Drug Reactions	2 participants

PRIMARY outcome

Timeframe: Week 4

Population: One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis

The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=32 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment	0 participants

PRIMARY outcome

Timeframe: Week 4

Population: One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis

The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=32 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment	0 participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment	0.005 mmol/L Standard Deviation 0.094

PRIMARY outcome

Timeframe: Baseline and 4 Weeks

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.	0.717 mmol/g Standard Deviation 2.877

SECONDARY outcome

Timeframe: Week 4

The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
"Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4.	20 participants

SECONDARY outcome

Timeframe: Week 4

The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
"Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.	23 participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Percentage Change in PASI From Baseline to Week 4.	-72.5 percentage Interval -81.1 to -63.9

SECONDARY outcome

Timeframe: 4 weeks

PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
PASI 75 at Week 4.	17 participants

SECONDARY outcome

Timeframe: Week 4

PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.

Outcome measures

Outcome measures
Measure	TACLONEX Ointment n=33 Participants TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
PASI 50 at Week 4.	28 participants

Adverse Events

TACLONEX Ointment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TACLONEX Ointment n=33 participants at risk TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
Infections and infestations Upper respiratory tract	6.1% 2/33
Nervous system disorders Headache	6.1% 2/33
Nervous system disorders Tension headache	6.1% 2/33
Respiratory, thoracic and mediastinal disorders Cough	6.1% 2/33
Skin and subcutaneous tissue disorders Rash papular	6.1% 2/33

Additional Information

Malin Järnkrants

LEO Pharma A/S

Phone: +45 7226 2990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Publication restrictions are in place

Restriction type: OTHER