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

This study has been completed.
Sponsor:
Collaborators:
CenTrial GmbH
d.s.h. statistical services GmbH
Information provided by (Responsible Party):
Dolorgiet GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01757613
First received: December 18, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis Olsen Grade I/II
Drug: AK 3012
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Three-armed, Randomized, Double-blind Dose-finding Trial on Efficiency and Safety of AK 3012 in 3 Different Concentrations in Patients With Actinic Keratosis Olsen Grade I/II

Resource links provided by NLM:


Further study details as provided by Dolorgiet GmbH & Co. KG:

Primary Outcome Measures:
  • Change of skin alterations during treatment period [ Time Frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of visible skin alterations during treatment period [ Time Frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90) ] [ Designated as safety issue: No ]
  • Tolerability of the investigated medicinal product [ Time Frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90) ] [ Designated as safety issue: Yes ]
    Tolerability will be assessed on the basis of adverse events

  • Adverse events [ Time Frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: December 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AK 3012 a for topical use Drug: AK 3012
cutaneous use twice a day
Active Comparator: AK 3012 b for topical use Drug: AK 3012
cutaneous use twice a day
Active Comparator: AK 3012 c for topical use Drug: AK 3012
cutaneous use twice a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥ 18 years
  • Gender: male and female
  • Actinic Keratosis (Olsen grade I/II)
  • at least 5 actinic keratoses on the scalp, forehead, face, extremities, and/ or decollete
  • no treatment of the actinic keratoses within the previous 3 months before inclusion in the study
  • histologic confirmation of the diagnosis actinic keratosis by biopsy
  • good general condition
  • normal laboratory values (creatinine, urea, Glutamate-Oxalacetate Transaminase (GOT),Glutamate-Pyruvate Transaminase (GPT), gamma-glutamyl transferase (GGT), Lactate dehydrogenase (LDH)) and blood count at study start not higher than 1.5 x upper norm limit
  • Female patients must be tested negative for pregnancy before inclusion in the trial. During the trial, female patients have to apply a generally accepted form of birth control (i.e. oral estrogen- and gestagen containing contraceptives; estrogen containing skin plaster/ tape, hormone implant, hormone contraceptive coil, sterilisation; sexual abstinence) or being post-menopausal for at least 2 years.
  • Willing and able to participate in the screening and all trial specific procedures in compliance with the protocol
  • Signed written informed consent

Exclusion Criteria:

  • Known allergy against nonsteroidal antiphlogistics and/ or against excipients of the investigational medicinal product
  • Presence of immunosuppression
  • Treatment with 5-fluorouracil, cyclosporine, retinoids, glycolic acid, imiquimod, trichloroacetic acid during the trial or 12 weeks before inclusion in the trial
  • Continuous treatment with nonsteroidal antiphlogistics with the exception of low-dose acetylsalicylic acid (100 mg) for inhibition of thrombocyte aggregation
  • Planned treatment with photodynamic therapy during participation in the trial
  • Pregnancy or lactation
  • Participation in another clinical trial within 3 months before inclusion in the current trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757613

Locations
Germany
Blaubeuren, Germany, 89143
Friedrichshafen, Germany, 88045
Hamburg, Germany, 22391
Langenau, Germany, 89129
Radolfzell, Germany, 78315
Stuttgart, Germany, 70190
Stuttgart, Germany, 70178
Stuttgart, Germany, 70499
Tuebingen, Germany, 72076
Sponsors and Collaborators
Dolorgiet GmbH & Co. KG
CenTrial GmbH
d.s.h. statistical services GmbH
Investigators
Principal Investigator: Amir Yazdi, Dr. med Eberhard-Karls-Universität Tübingen
Study Director: Angelika Trapp Dolorgiet GmbH & Co. KG
  More Information

No publications provided

Responsible Party: Dolorgiet GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01757613     History of Changes
Other Study ID Numbers: KER-001, 2012-002529-30
Study First Received: December 18, 2012
Last Updated: May 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 20, 2014