Trial Outcomes & Findings for Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis (NCT NCT01083758)

NCT ID: NCT01083758

Last Updated: 2025-03-11

Results Overview

Adverse events for which the investigator did not describe the causal relationship to IP as not related

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Throughout trial, up to 8 weeks
• Results posted on: 2025-03-11

Participant Flow

Start date: 12 April 2010 Completion date: 8 August 2012

Prior to Visit 1 (Day 0), a wash-out period (up to 8 weeks, as defined by the exclusion criteria) was to be completed if the subject had been treated with antipsoriatic treatments or other relevant medication; 2 screening visits were planned.

Participant milestones

Measure	LEO 80185 Gel Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Overall Study STARTED	31
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

Baseline characteristics by cohort

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Age, Categorical <=18 years	31 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14.8 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Throughout trial, up to 8 weeks

Adverse events for which the investigator did not describe the causal relationship to IP as not related

Outcome measures

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Percentage of Subjects With Adverse Drug Reactions (ADRs)	3.2 percentage of participants

PRIMARY outcome

Timeframe: Week 4

Population: Per Protocol Population (based on the Full Analysis Set, but excluding subjects who did not apply any study medication, meet the inclusion criterion concerning adrenal function at baseline, or provide any results for the ACTH-challenge test after receiving study treatment)

Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.

Outcome measures

Measure	LEO 80185 Gel n=30 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4	1 participants

PRIMARY outcome

Timeframe: week 8

Population: Per Protocol Population

Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.

Outcome measures

Measure	LEO 80185 Gel n=26 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8	0 participants

PRIMARY outcome

Timeframe: week 4

Population: Per Protocol Population

Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.

Outcome measures

Measure	LEO 80185 Gel n=29 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.	0 participants

PRIMARY outcome

Timeframe: week 8

Population: Per protocol population

Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.

Outcome measures

Measure	LEO 80185 Gel n=25 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.	0 participants

PRIMARY outcome

Timeframe: Baseline and week 4

Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=30 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.	-0.028 mmol/L Standard Deviation 0.087

PRIMARY outcome

Timeframe: Baseline and week 8

Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=26 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.	0.002 mmol/L Standard Deviation 0.087

PRIMARY outcome

Timeframe: Baseline and end of treatment (up to 8 weeks)

Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=30 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.	-0.007 mmol/L Standard Deviation 0.090

PRIMARY outcome

Timeframe: Baseline and week 4

Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=28 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.	0.20 mmol/24h Standard Deviation 2.26

PRIMARY outcome

Timeframe: Baseline and week 8

Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=22 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.	0.06 mmol/24h Standard Deviation 2.35

PRIMARY outcome

Timeframe: Baseline and end of treatment (up to 8 weeks)

Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=29 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.	0.12 mmol/24h Standard Deviation 2.14

PRIMARY outcome

Timeframe: Baseline and week 4

Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=28 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.	-0.179 mmol/g Standard Deviation 1.848

PRIMARY outcome

Timeframe: Baseline and week 8

Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=22 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.	-0.005 mmol/g Standard Deviation 2.379

PRIMARY outcome

Timeframe: Baseline and end of treatment (up to 8 weeks)

Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.

Outcome measures

Measure	LEO 80185 Gel n=29 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.	0.096 mmol/g Standard Deviation 2.142

SECONDARY outcome

Timeframe: Baseline and week 4

Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8

Outcome measures

Measure	LEO 80185 Gel n=27 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8	-3.2 ng/L Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline and week 8

Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8

Outcome measures

Measure	LEO 80185 Gel n=25 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8	-2.4 ng/L Standard Deviation 15.2

SECONDARY outcome

Timeframe: week 2

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.

Outcome measures

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	32.3 percentage of participants

SECONDARY outcome

Timeframe: week 4

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.

Outcome measures

Measure	LEO 80185 Gel n=30 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	43.3 percentage of participants

SECONDARY outcome

Timeframe: week 8

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.

Outcome measures

Measure	LEO 80185 Gel n=26 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	53.8 percentage of participants

SECONDARY outcome

Timeframe: End of treatment

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.

Outcome measures

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	54.8 percentage of participants

SECONDARY outcome

Timeframe: week 2

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Outcome measures

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.	-48.0 Percentage change Standard Deviation 31.0

SECONDARY outcome

Timeframe: Baseline and week 4

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Outcome measures

Measure	LEO 80185 Gel n=30 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.	-48.8 percentage change Standard Deviation 29.9

SECONDARY outcome

Timeframe: Baseline and week 8

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Outcome measures

Measure	LEO 80185 Gel n=26 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.	-57.2 Percentage change Standard Deviation 33.9

SECONDARY outcome

Timeframe: Baseline and end of treatment (up to 8 weeks)

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Outcome measures

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.	-59.2 Percentage change Standard Deviation 35.4

SECONDARY outcome

Timeframe: week 2

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.

Outcome measures

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	45.2 % of participants w/ controlled disease

SECONDARY outcome

Timeframe: week 4

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.

Outcome measures

Measure	LEO 80185 Gel n=30 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	50.0 % of participants w/ controlled disease

SECONDARY outcome

Timeframe: week 8

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.

Outcome measures

Measure	LEO 80185 Gel n=26 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	57.7 % of participants w/ controlled disease

SECONDARY outcome

Timeframe: End of treatment

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.

Outcome measures

Measure	LEO 80185 Gel n=31 Participants Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.	58.1 % of participants w/ controlled disease

Adverse Events

LEO 80185 Gel

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LEO 80185 Gel n=31 participants at risk Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
Respiratory, thoracic and mediastinal disorders Cough	9.7% 3/31
Infections and infestations Nasopharyngitis	6.5% 2/31
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.7% 3/31
Infections and infestations Upper respiratory tract	6.5% 2/31

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: ctr.disclosure@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee LEO acknowledges the investigators' right to publish the results of the trial, irrespective of outcome. Pubs/presentations by investigator(s) shall not be made before the results of a joint publication is public. LEO retains the right to have any publication submitted to LEO for review at least 30 days prior to this paper being submitted for publication/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