NCT01757613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

December 18, 2012

Last Update Submit

May 13, 2014

Conditions

Actinic Keratosis Olsen Grade I/II

Outcome Measures

Primary Outcomes (1)

  • Change of skin alterations during treatment period

    90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

Secondary Outcomes (3)

  • Change of visible skin alterations during treatment period

    90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

  • Tolerability of the investigated medicinal product

    90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

  • Adverse events

    90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

Study Arms (3)

AK 3012 a for topical use

ACTIVE COMPARATOR
Drug: AK 3012

AK 3012 b for topical use

ACTIVE COMPARATOR
Drug: AK 3012

AK 3012 c for topical use

ACTIVE COMPARATOR
Drug: AK 3012

Interventions

AK 3012DRUG

cutaneous use twice a day

AK 3012 a for topical useAK 3012 b for topical useAK 3012 c for topical use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • Willing and able to participate in the screening and all trial specific procedures in compliance with the protocol
  • Signed written informed consent

You may not qualify if:

  • Known allergy against nonsteroidal antiphlogistics and/ or against excipients of the investigational medicinal product
  • Presence of immunosuppression
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Blaubeuren Abbey, 89143, Germany

Location

Unknown Facility

Friedrichshafen, 88045, Germany

Location

Unknown Facility

Hamburg, 22391, Germany

Location

Unknown Facility

Langenau, 89129, Germany

Location

Unknown Facility

Radolfzell, 78315, Germany

Location

Unknown Facility

Stuttgart, 70178, Germany

Location

Unknown Facility

Stuttgart, 70190, Germany

Location

Unknown Facility

Stuttgart, 70499, Germany

Location

Unknown Facility

Tübingen, 72076, Germany

Location

Study Officials

  • Amir Yazdi, Dr. med

    Eberhard-Karls-Universität Tübingen

    PRINCIPAL INVESTIGATOR

  • Angelika Trapp

    Dolorgiet GmbH & Co. KG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 31, 2012

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

DE(9)