Trial Outcomes & Findings for Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis (NCT NCT01195831)

Results Overview

Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

244 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-03-12

Participant Flow

The study period was 17 September 2010 (date of the first enrolment) to 01 March 2011 (date of last patient out)

Participant milestones

Participant milestones
Measure	Xamiol® Gel Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution Calcipotriol (as hydrate) 50 mcg/ml
Overall Study STARTED	120	124
Overall Study COMPLETED	112	114
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Xamiol® Gel Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution Calcipotriol (as hydrate) 50 mcg/ml
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	2	2
Overall Study Adverse Event	4	2
Overall Study Protocol Violation	0	2

Baseline Characteristics

Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xamiol® Gel n=120 Participants Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 Participants Calcipotriol (as hydrate) 50 mcg/ml	Total n=244 Participants Total of all reporting groups
Age, Continuous	39.87 years STANDARD_DEVIATION 13.145 • n=5 Participants	38.73 years STANDARD_DEVIATION 11.869 • n=7 Participants	39.29 years STANDARD_DEVIATION 12.500 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	55 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	69 Participants n=7 Participants	142 Participants n=5 Participants
Region of Enrollment China	120 participants n=5 Participants	124 participants n=7 Participants	244 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.

Outcome measures

Outcome measures
Measure	Xamiol® Gel n=120 Participants Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 Participants Calcipotriol (as hydrate) 50 mcg/ml
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.	87.5 percentage of parcipitants	50.8 percentage of parcipitants

SECONDARY outcome

Timeframe: 2 weeks

Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease.

Outcome measures

Outcome measures
Measure	Xamiol® Gel n=120 Participants Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 Participants Calcipotriol (as hydrate) 50 mcg/ml
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2	80.8 percentage of participants	25.8 percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.

Outcome measures

Outcome measures
Measure	Xamiol® Gel n=120 Participants Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 Participants Calcipotriol (as hydrate) 50 mcg/ml
Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.	79.2 percentage of participants	37.1 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.

Outcome measures

Outcome measures
Measure	Xamiol® Gel n=120 Participants Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 Participants Calcipotriol (as hydrate) 50 mcg/ml
Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.	90.8 percentage of participants	60.5 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved "Success".

Outcome measures

Outcome measures
Measure	Xamiol® Gel n=120 Participants Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 Participants Calcipotriol (as hydrate) 50 mcg/ml
Patients With Success (Total Sign Score ≤1) at Week 4	64.2 percentage of participants	25.8 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to weeks 2 and 4

Outcome measures

Outcome data not reported

Adverse Events

Xamiol® Gel

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Calcipotriol Scalp Solution

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Xamiol® Gel n=118 participants at risk Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 participants at risk Calcipotriol (as hydrate) 50 mcg/ml
Injury, poisoning and procedural complications Limb crushing injury	0.85% 1/118 • Number of events 1 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)	0.00% 0/124 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.85% 1/118 • Number of events 1 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)	0.00% 0/124 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)

Other adverse events

Other adverse events
Measure	Xamiol® Gel n=118 participants at risk Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Calcipotriol Scalp Solution n=124 participants at risk Calcipotriol (as hydrate) 50 mcg/ml
General disorders Application site pain	2.5% 3/118 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)	11.3% 14/124 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)
General disorders Application site warmth	0.85% 1/118 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)	10.5% 13/124 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	9.3% 11/118 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)	7.3% 9/124 The Number of participants at risk is based on the number of participants included in the safety analysis set, i.e. all randomized patients who had at least one dose of medication, and had at least one post-baseline safety assessment (118 out of 120 patients in Xamiol® gel group and all (124) patients in Calcipotriol scalp solution group)

Additional Information

Malin Jaernkrants

Leo Pharma

Phone: +4544945888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The company acknowledges the investigators' right to publish the results of the trial. The company retains the right to have any publication submitted to the company for review at least 30 days prior to the proposed submission or presentation date. Investigators must undertake not to submit any part of their individual data for publication without prior consent of LEO.
Publication restrictions are in place

Restriction type: OTHER