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Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis

NCT01757613 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-05-14

No results posted yet for this study

Summary

In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation.

The main objective of the trial is to determine the optimal concentration of the active agent in the topical formulation as quantified by the change of the number of skin alterations in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing.

Conditions

  • Actinic Keratosis Olsen Grade I/II

Interventions

DRUG

AK 3012

cutaneous use twice a day

Sponsors & Collaborators

  • CenTrial GmbH

    collaborator INDUSTRY

  • d.s.h. statistical services GmbH

    collaborator UNKNOWN

  • Dolorgiet GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Amir Yazdi, Dr. med · Eberhard-Karls-Universität Tübingen

  • Angelika Trapp · Dolorgiet GmbH & Co. KG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757613 on ClinicalTrials.gov