search
Back to results

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

Primary Purpose

Actinic Keratosis Olsen Grade I/II

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
AK 3012
Sponsored by
Dolorgiet GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis Olsen Grade I/II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

AK 3012 a for topical use

AK 3012 b for topical use

AK 3012 c for topical use

Arm Description

Outcomes

Primary Outcome Measures

Change of skin alterations during treatment period

Secondary Outcome Measures

Change of visible skin alterations during treatment period
Tolerability of the investigated medicinal product
Tolerability will be assessed on the basis of adverse events
Adverse events

Full Information

First Posted
December 18, 2012
Last Updated
May 13, 2014
Sponsor
Dolorgiet GmbH & Co. KG
Collaborators
CenTrial GmbH, d.s.h. statistical services GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01757613
Brief Title
Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dolorgiet GmbH & Co. KG
Collaborators
CenTrial GmbH, d.s.h. statistical services GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis Olsen Grade I/II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK 3012 a for topical use
Arm Type
Active Comparator
Arm Title
AK 3012 b for topical use
Arm Type
Active Comparator
Arm Title
AK 3012 c for topical use
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AK 3012
Intervention Description
cutaneous use twice a day
Primary Outcome Measure Information:
Title
Change of skin alterations during treatment period
Time Frame
90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Secondary Outcome Measure Information:
Title
Change of visible skin alterations during treatment period
Time Frame
90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Title
Tolerability of the investigated medicinal product
Description
Tolerability will be assessed on the basis of adverse events
Time Frame
90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Title
Adverse events
Time Frame
90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Yazdi, Dr. med
Organizational Affiliation
Eberhard-Karls-Universität Tübingen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angelika Trapp
Organizational Affiliation
Dolorgiet GmbH & Co. KG
Official's Role
Study Director
Facility Information:
City
Blaubeuren
ZIP/Postal Code
89143
Country
Germany
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
City
Langenau
ZIP/Postal Code
89129
Country
Germany
City
Radolfzell
ZIP/Postal Code
78315
Country
Germany
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
City
Stuttgart
ZIP/Postal Code
70190
Country
Germany
City
Stuttgart
ZIP/Postal Code
70499
Country
Germany
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs