Clinical study reports and summaries

In accordance with LEO Pharma's position on transparency, clinical study reports and summaries of clinical trials sponsored by LEO Pharma going back to 1990 have been made publicly available on this website.

Clinical study reports

Clinical study reports are the formal reports produced according to ICH guidelines following the completion of a clinical trial. They comprise detailed information on the methods, design and results of the clinical trial. Clinical study reports are used as a primary source of documentation in marketing authorisation applications submitted to health authorities.

Clinical study reports of trials investigating products in approved indications are posted on LEO Pharma corporate website after decision and accomplishment of peer-reviewed publication in scientific journals. If publication is not pursued, the clinical study report is posted within 12 months of trial completion. Posting of clinical study reports includes also clinical trials in abandoned projects (trials from 2014 and onwards).

Clinical study reports are posted on this website without appendices or patient level data. Access to patient level data from clinical trials dating back to 2000 can be requested for scientific purposes as soon as the clinical study report from that clinical trial has been posted on this site.

Summaries

Summaries provide a short overview of the purpose, results, and conclusion of the clinical trial. The summary is often a section of the clinical study report. Summaries of clinical trials from 2014 and onwards are posted on LEO Pharma corporate website within 12 months of trial completion, irrespectively of approval status of the investigated compound, including abandoned projects. For previous trials (1990 - 2013), summaries are posted for these trials investigating products in approved indications.

 

Protection of patient's privacy

Transparency is not an end in itself. It should not be at the expense of protecting an individual patient’s privacy. LEO Pharma, as the sponsor of a clinical trial, has made a commitment to patients to protect their privacy by safeguarding their personal data and restricting the use of data from clinical trials to respect the scope of the patients informed consent.

This commits us to redact sensitive personal information contained in clinical study reports and summaries. Furthermore, we will redact certain commercially confidential information and personal data relating to experts and staff involved in conducting the clinical trials before posting those documents on this site and making the patient level data available.

Clinical study reports and sum

Below is a list of currently published clinical study reports and summaries. By using the search function to the right it is furthermore possible to do a free text search in all published clinical study reports and summaries.

Available documents are listed according to indication:

Actinic Keratosis
Hypertension and edema
Psoriasis
Skin infection
Thrombosis

Documents are also grouped based whether the trial are from 1 January 1990 to 31 December 2013, or from 1 January 2014 and onwards.

Clinical Trials from 1 January 1990 - 31 December 2013

Actinic Keratosis

PEP005 014: A multi-center, randomized, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) Gel, 0.05% in patients with actinic keratoses on non-head locations (REGION-I)
Summary (PDF)   

PEP005 017: A randomized, double-blind, vehicle-controlled study to evaluate the pharmacokinetics of PEP005 (ingenol mebutate) Gel, 0.05%, when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratosis
Summary (PDF)   

PEP 005 015: A multicenter, randomized, double-blind, vehicle-controlled, dose-ranging study to evaluate the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when used to treat actinic keratoses on the head (face or scalp)
Summary (PDF)

Hypertension and edema

CE 0701 DK: Single dose bioequivalence study of Centyl® K, LEO new tablet formulation vs existing formulation of Centyl® K in healthy subjects of either sex.
Summary (PDF)

Psoriasis

LP0076 57: A short-contact plaque test study with Daivobet® gel in psoriasis vulgaris
Summary (PDF)

MCB 0903: Efficacy and safety of LEO 90105 ointment (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris
Summary (PDF)

MCB 0501 INT: Safety and efficacy of TACLONEX ointment in adolescent patients (aged 12 to 17 years) with psoriasis vulgaris
Summary (PDF)

LEO80185 G24: Effect of LEO 80185 Gel on the HPA axis and Calcium Metabolism in Subjects with Extensive Psoriasis Vulgaris
Summary (PDF)

LEO80185 G23: Calcipotriol plus betamethasone dipropionate topical suspension compared to betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle and the topical suspension vehicle alone in psoriasis vulgaris
Summary (PDF)

MCB 0902: Multiple Dose Study of LEO 90105 – Calcipotriol 50 mcg/g and Betamethasone 0.5 mg/g (as Dipropionate)
Summary (PDF)

MBL 0802 CN: Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients with Scalp Psoriasis
Summary (PDF)

MCB 0901: Skin Irritation Test of LEO 90105 – Calcipotriol 50 mcg/g and Betamethasone 0.5 mg/g (as Dipropionate)
Summary (PDF)

PLQ-002: A plaque test comparing the anti-psoriatic effect of marketed products for topical use for psoriasis vulgaris 
Summary (PDF)

LEO80185-G21: Efficacy and Safety of Calcipotriol plus Betamethasone Dipropionate Gel Compared with Tacalcitol Ointment and the Gel Vehicle Alone in Patients with Psoriasis Vulgaris 
Summary (PDF)

PLQ-001: A plaque test comparing three marketed products and two investigational products and a vehicle control for the treatment of psoriasis vulgaris 
Summary (PDF)

MCB 0402 INT: Different treatment regimens of calcipotriol cream and combination (calcipotriol/betamethasone dipropionate) ointment in psoriasis vulgaris
Summary (PDF)

MBL 0502 US:Calcipotriene plus betamethasone dipropionate gel compared to the gel vehicle in scalp psoriasis, in patients receiving calcipotriene plus betamethasone dipropionate ointment for psoriasis vulgaris of trunk/limbs
Summary (PDF)

MCB 0904: The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris
Summary (PDF)

WCO 0501 US: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy of Taclonex® (Calcipotriene, 0.005% and Betamethasone, 0.05%) Ointment Compared to Dovonex® (Calcipotriene Ointment, 0.005%) in the Treatment of Psoriasis Vulgaris
Summary (PDF)

MBL 0501 FR: In vivo bioequivalence study of betamethasone dipropionate in DAIVOBET/DOVOBET gel and DIPROSONE lotion according to FDA Guideline for vasoconstrictor bioassay
Summary (PDF)

MBL 0601 FR: Assessment of the Atrophogenic Potential and Dermal Tolerance of DAIVOBET/DOVOBET Gel Compared with Diprosone® Ointment 
Summary (PDF)

MBL 0403 FR: In vivo bioequivalence study of betamethasone dipropionate in DAIVOBET/DOVOBET gel and DIPROSONE ointment according to FDA Guideline for vasoconstrictor bioassay
Summary (PDF)

MBL 0404 FR: Effect of DAIVOBET/DOVOBET Gel on the HPA Axis and Calcium Metabolism in Patients with Extensive Scalp Psoriasis
Summary (PDF)

MBL 0407 INT: Long-term Treatment of Scalp Psoriasis with Calcipotriol plus Betamethasone Dipropionate Gel
Summary (PDF)

MBL 0503 INT: DAIVOBET/DOVOBET Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients with Scalp Psoriasis 
Summary (PDF)

MBL 0402 UK: Assessment of the atrophogenic potential and dermal tolerance of DAIVOBET/DOVOBET gel compared with Diprosone® Ointment
Summary (PDF)

MBL 0202 INT: Calcipotriol plus betamethasone dipropionate gel compared to betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone in psoriasis vulgaris
Summary (PDF)

Skin infection

FUC 0301 INT: Fucidin® cream in the treatment of impetigo/FUC 0301 INT
Summary (PDF)

Thrombosis

IN0201 ES: Single doses of Tinzaparin in the prevention og coagulation in haemodialysis lasting more than 4 hours/IN 0201 ES
Summary (PDF)

IN 0401 INT: Safety profile of innohep® versus subcutaneous unfractionated heparin in eldery patients with impaired renal function treated for acute deep vein thrombosis
Summary (PDF)

The first clinical study reports will be uploaded by end of March 2014