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Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

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ClinicalTrials.gov Identifier: NCT02549352
Recruitment Status : Completed
First Posted : September 15, 2015
Results First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: LEO43204 gel Drug: Vehicle gel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Study Start Date : November 2015
Actual Primary Completion Date : September 22, 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LEO 43204 gel
Treatment once daily for 3 days
Drug: LEO43204 gel
Other Name: Ingenol Disoxate

Placebo Comparator: Vehicle gel
Treatment once daily for 3 days
Drug: Vehicle gel



Primary Outcome Measures :
  1. Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) [ Time Frame: At Week 8 ]

    The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8.

    Complete clearance was defined as no clinically visible AKs in the treatment area.

    The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.



Secondary Outcome Measures :
  1. Percentage of Participants With Partial Clearance [ Time Frame: At Week 8 ]

    The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.

    Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

    The table shows the percentage of mean number of participants across imputations with partial clearance at Week 8.


  2. Percentage of Participants With Partial Clearance [ Time Frame: At Week 4 ]

    The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.

    Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

    The table shows the percentage of mean number of participants across imputations with partial clearance at Week 4.


  3. Percent Reduction in AK Count in the Treatment Area Compared to Baseline [ Time Frame: At Week 8 ]
    The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
  • Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area

Exclusion Criteria:

  • Location of the treatment area (balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
  • Treatment with ingenol mebutate gel in the treatment area within the last 12 months
  • Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
  • History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549352


Locations
Germany
Klinik für Dermatologie & Allergologie Klinikum Vest GmbH
Recklinghausen, Germany, 45657
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Rolf-Markus Szeimies, Prof. Dr.med Klinik für Dermatologie & Allergologie Klinikum Vest GmbH

Additional Information:
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02549352     History of Changes
Other Study ID Numbers: LP0084-1196
First Posted: September 15, 2015    Key Record Dates
Results First Posted: December 25, 2018
Last Update Posted: December 25, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms