CompletedPhase 2

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

United States30 participantsStarted 2017-06-06

Plain-language 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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject must provide written informed consent.
✓. Subject must be male or non-pregnant females of any race, and any skin type aged 18 to 80 years both inclusive.
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. 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.

✕. Subject has very thick and/or hyperkeratotic actinic keratosis AK lesions in the treatment area.
✕. 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.
✕. 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.
✕. 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.
✕. 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.
✕. Subject has untreated basal cell carcinoma, squamous cell carcinoma or melanoma in the treatment area.
✕. Subject has suntan or tattoos that may interfere with the assessments in the treatment area.
✕. 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.

Complete clearance of all lesions

Timeframe: 8 weeks post treatment

NCT IDNCT03210740

SponsorAmDerma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-13

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject must provide written informed consent.
✓. Subject must be male or non-pregnant females of any race, and any skin type aged 18 to 80 years both inclusive.
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. 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.

✕. Subject has very thick and/or hyperkeratotic actinic keratosis AK lesions in the treatment area.
✕. 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.
✕. 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.
✕. 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.
✕. 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.
✕. Subject has untreated basal cell carcinoma, squamous cell carcinoma or melanoma in the treatment area.
✕. Subject has suntan or tattoos that may interfere with the assessments in the treatment area.
✕. 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.