Intervention: HYDROGEN PEROXIDE
Trial phase: Phase 1 | Phase 2
ATC code: A01AB02 | D08AX01 | D11AX25 | S02AA06
SMILES: OO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: High Dose Group

A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions
Eligibility criteria:
Inclusion Criteria:

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).

Exclusion Criteria:

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:

Retinoids; 180 days
Glucocorticosteroids; 28 days
Anti-metabolites (e.g., methotrexate); 28 days

Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:

Retinoids; 90 days
Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
Glucocorticosteroids or antibiotics; 14 days
Moisturizers/emollients, sunscreens; 12 hours
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
Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area
Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
Has experienced a sunburn on the treatment area within the previous 4 weeks
Has a history of sensitivity to any of the ingredients in the study medications
Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.