Safety and Efficacy Study of AM001 Cream in the Treatment of Actinic Keratosis

April 25, 2019 updated by: AmDerma

A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK) Lesions

To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of Actinic Keratosis (AK) Lesions

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK) Lesions

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • AmDerma Pharmaceuticals, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must provide written informed consent.
  2. Subject must be male or non-pregnant females of any race, and any skin type aged 18 to 80 years both inclusive.
  3. Subject has 4 to 8 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter within a 25cm² contiguous treatment area on the face or the balding scalp.
  4. Subject is willing to avoid exposure to sunlight, use of tanning booths, sunlamps, or nonprescription UV (ultra-violate) light sources during the study period.ooths, sunlamps, or nonprescription UV (ultra-violate) light sources during the study period.
  5. If female subject of childbearing potential, the subject must have a negative urine pregnancy test at Visit 1/ Screening and must have been using an acceptable form of birth control for at least 2 months prior to Visit 1/ Screening and is willing to continue birth control during the study.
  6. Subject must be willing and able to understand and comply with the requirements of the study, apply the assigned investigational product as instructed, return for the required study visits, comply with therapy prohibitions.
  7. Subject must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/condition, other than actinic keratosis, that might interfere with the study evaluations.

Exclusion Criteria:

  1. Subject has very thick and/or hyperkeratotic actinic keratosis AK lesions in the treatment area.
  2. Subject has used topical treatment of actinic keratosis in the treatment area with 5-fluorouracil, imiquimod, diclofenac, corticosteroids or retinoids within 1 month prior to Visit 2/Baseline or during the study.
  3. Subject has used treatment with PDT (photodynamic therapy) or physical therapies (e. g. cryotherapy, curettage or surgical treatment) in the treatment area within 1 month prior to Visit 2/Baseline or during the study.
  4. Subject has used chemical peel, dermabrasion, laser abrasion, PUVA (prosalen plus ultraviolet A) therapy or UVB therapy within 6 months prior to Visit 2/Baseline or during the study.
  5. Subject has used immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids, oral retinoids or cytotoxic drugs within 1 month prior to Visit 2/Baseline or during the study.
  6. Subject has untreated basal cell carcinoma, squamous cell carcinoma or melanoma in the treatment area.
  7. Subject has suntan or tattoos that may interfere with the assessments in the treatment area.
  8. Subject has dermatological diseases in the treatment area that may interfere with the assessments, e.g. acute skin inflammation, atopic dermatitis, eczema, rosacea, psoriasis, seborrheic dermatitis, peri-oral dermatitis or hyperpigmentation.
  9. Subject who consumes excessive amount of alcohol, abuse or have any condition that in the investigator's opinion would compromise compliance, with this protocol.
  10. Subject has history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin.
  11. Female subject who is pregnant, nursing or planning a pregnancy within the study participation period
  12. Subject has symptoms of a clinically significant illness that may influence the outcome of the study in the 4 weeks prior to Visit 1/Screening.
  13. Subject has participated in another clinical trial involving investigational product or device in the 4 weeks prior to Visit 1/Screening.
  14. Subject has known allergic reactions to components of the investigational product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: AM001 Cream, 7.5%
A white to off-white Cream free from any foreign particles
Drug: AM001 Cream, 7.5%
Active Cream
Other Names:
  • Potassium Dobesilate
PLACEBO_COMPARATOR: Vehicle Cream
A white to off-white Cream free from any foreign particles
Drug: Vehicle Cream
Placeo
Other Names:
  • Placebo Cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete clearance of all lesions
Time Frame: 8 weeks post treatment
(100 % of all AK lesions cleared) 8 weeks post treatment
8 weeks post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete clearance of all baseline lesions weeks of treatment
Time Frame: 16 weeks
(100% of baseline AK lesions cleared) after 16 weeks of treatment
16 weeks
Complete clearance of all lesions
Time Frame: 12 weeks
(100% of baseline AK lesions cleared) after 12 weeks of treatment
12 weeks
Complete clearance of all lesions
Time Frame: 8 weeks
(100% of baseline AK lesions cleared) after 8 weeks of treatment
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AmDerma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AD-AM001-AK1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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