CompletedPhase 1/2

Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

United States35 participantsStarted 2013-10-22

Plain-language summary

Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.

Age range18 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.

✓. Is at least 18 years of age
✓. Has a clinical diagnosis of stable clinically typical seborrheic keratosis
✓. Has at least 4 appropriate seborrheic keratosis target lesions on the back
✓. If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
✓. Is non-pregnant and non-lactating
✓. Is in good general health and free of any disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation
✓. Is willing and able to follow all study instructions and to attend all study visits
✓. Is able to comprehend and willing to sign an Informed Consent Form (ICF).

✕. Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
✕. Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
✕. Has used any of the following systemic therapies within the specified period prior to Visit 1:
✕. Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
✕. Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
✕. Has a history of keloid formation or hypertrophic scarring
✕. Has a current systemic malignancy
✕. Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area

Mean Change in Physician Lesion Assessment Scale

Timeframe: Visit 2 to visit 9 (78 days)

NCT IDNCT01986920

SponsorAclaris Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02-25

Results submitted2017-01-09

Who can participate

Age range18 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.

✓. Is at least 18 years of age
✓. Has a clinical diagnosis of stable clinically typical seborrheic keratosis
✓. Has at least 4 appropriate seborrheic keratosis target lesions on the back
✓. If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
✓. Is non-pregnant and non-lactating
✓. Is in good general health and free of any disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation
✓. Is willing and able to follow all study instructions and to attend all study visits
✓. Is able to comprehend and willing to sign an Informed Consent Form (ICF).

✕. Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
✕. Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
✕. Has used any of the following systemic therapies within the specified period prior to Visit 1:
✕. Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
✕. Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
✕. Has a history of keloid formation or hypertrophic scarring
✕. Has a current systemic malignancy
✕. Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area