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Clinical Trials/EUCTR2014-000037-23-DE
EUCTR2014-000037-23-DE
Active, not recruiting
Phase 1

Clinical Study ProtocolSafety and efficacy of escalating doses of LEO 43204 applied once daily for two consecutive days on full balding scalp in subjects with actinic keratosisPart 1: A phase 1, multicentre, open-label,dose escalation, 2-week trialPart 2: A phase 2, multicentre, randomised, double-blind, parallel group,vehicle-controlled, 8-week trial

EO Pharma A/S0 sites220 target enrollmentMay 9, 2014
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ConditionsActinic KeratosisMedDRA version: 17.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Actinic Keratosis
Sponsor
EO Pharma A/S
Enrollment
220
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 9, 2014
End Date
March 2, 2015
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
EO Pharma A/S

Eligibility Criteria

Inclusion Criteria

  • •Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp.
  • •Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 110
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 110

Exclusion Criteria

  • •Location of the treatment area:
  • •\- within 5 cm of an incompletely healed wound
  • •\- within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  • •Prior treatment with ingenol mebutate gel on the treatment area
  • •Lesions in the treatment areas that have
  • •\- atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
  • •\- recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Outcomes

Primary Outcomes

Not specified

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