Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210740
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
AmDerma

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

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: AM001 Cream, 7.5% Drug: Vehicle Cream Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : April 24, 2018

Arm Intervention/treatment
Experimental: AM001 Cream, 7.5%
A white to off-white Cream free from any foreign particles
Drug: AM001 Cream, 7.5%
Active Cream
Other Name: Potassium Dobesilate

Placebo Comparator: Vehicle Cream
A white to off-white Cream free from any foreign particles
Drug: Vehicle Cream
Placeo
Other Name: Placebo Cream




Primary Outcome Measures :
  1. Complete clearance of all lesions [ Time Frame: 8 weeks post treatment ]
    (100 % of all AK lesions cleared) 8 weeks post treatment


Secondary Outcome Measures :
  1. Complete clearance of all baseline lesions weeks of treatment [ Time Frame: 16 weeks ]
    (100% of baseline AK lesions cleared) after 16 weeks of treatment

  2. Complete clearance of all lesions [ Time Frame: 12 weeks ]
    (100% of baseline AK lesions cleared) after 12 weeks of treatment

  3. Complete clearance of all lesions [ Time Frame: 8 weeks ]
    (100% of baseline AK lesions cleared) after 8 weeks of treatment



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210740


Locations
Layout table for location information
United States, North Carolina
AmDerma Pharmaceuticals, LLC
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
AmDerma
Layout table for additonal information
Responsible Party: AmDerma
ClinicalTrials.gov Identifier: NCT03210740    
Other Study ID Numbers: AD-AM001-AK1
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms