- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02669862
A Study of A-101 Solution in Subjects With Common Warts.
A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
-
Wayne, Pennsylvania, Forente stater, 19087
- Aclaris Therapeutics, Inc.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject has a clinical diagnosis of common warts
Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:
- Have a longest axis that is 3mm to 10mm
- Have a thickness ≤3mm
- Be a discrete lesion
- Be, when centered in the circular cutout of the provided template, the only common wart present
- Not be periungual, subungual, genital or anal
- Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatments or the study evaluations Not be in an area that may be occluded (by clothing, footwear or within a skin fold).
- The Target Wart has a Physician Wart Assessment (PWA) ≥2
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
- Subject is non-pregnant and non-lactating
- Subject is in good general health and free of any known disease state or physical condition which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
- Subject is willing and able to follow all study instructions and to attend all study visits
- Subject is able to comprehend and willing to sign an Informed Consent Form.
Exclusion Criteria:
- Subject has clinically atypical warts on the trunk or extremities
- Subject is immune compromised (due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
- Subject has a history of Human Immunodeficiency Virus (HIV) infection
- Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to enrollment
Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:
- Immunotherapy (Candida antigen, mumps antigen, Trichophyton antigen);
- Anti-metabolite therapy (bleomycin, 5-fluorouracil)
Subject has used any of the following systemic therapies within the specified period prior to enrollment:
- Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab);
- Glucocortico-steroids (inhaled and intra-nasal steroids are permitted);
Subject has used any of the following topical therapies within the specified period prior to enrollment on, or in a proximity to the Target Wart, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
- LASER (pulsed-dye laser), light (intense pulsed light, photo-dynamic therapy, other energy based therapy); Immuno-therapy ( imiquimod, squaric acid dibutyl ester, etc.); Anti-metabolite therapy (5-fluorouracil); Retinoids; Liquid nitrogen, electrodesiccation, curettage; Over-the-counter wart therapies
Subject has had any of the following within the specified period prior to enrollment on, or in a proximity to the target lesion, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
- A cutaneous malignancy;
- A pre-malignancy (actinic keratosis)
- Subject has a history of sensitivity to any of the ingredients in the study medications
- Subject has any current skin disease (psoriasis, atopic dermatitis, eczema, sun damage, etc.), skin condition (sunburn, open wounds) or other disease or condition (uncontrolled diabetes) which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
- Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: A-101 Solution 40
A-101 Solution 40% administered once per week
|
|
Eksperimentell: A-101 Solution 45
A-101 Solution 45% administered once per week
|
|
Placebo komparator: Vehicle Solution
Vehicle Solution administered once per week
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Tidsramme: 57 Days
|
The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate.
Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.
|
57 Days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
Tidsramme: visit 10 to visit 13
|
Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups
|
visit 10 to visit 13
|
PWA Responder
Tidsramme: Day 57
|
The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
|
Day 57
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Stuart D Shanler, MD, Aclaris Therapeutics, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A-101-WART-201
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