Evaluation of a Topical Treatment for Actinic Keratosis

NCT01921907 | Completed Phase 2

• 1 other identifier: AD17137
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.

Conditions

Actinic Keratosis of Face and Scalp

Keywords

Actinic keratosis; topical; dermatology; treatment; clinical study; double blinded

Outcome Measures

Primary Outcomes (1)

• Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.

  baseline to Week 7

Secondary Outcomes (5)

• Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.

  baseline to Week 7

• Mean change in lesion size

  baseline to Week 7

• Change in Investigator Global Assessment

  baseline to Week 7

• Mean change in lesion number

  baseline to Week 7

• Change in Patient Global Assessment

  baseline to Week 7

Study Arms (2)

Active

EXPERIMENTAL

topical treatment

Drug: AD17137 topical treatment

Placebo

PLACEBO COMPARATOR

topical treatment

Drug: Placebo

Interventions

AD17137 topical treatment DRUG

Active

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 30 to 90 years old, inclusive, in good general health
• Clinical diagnosis of Actinic Keratosis
• At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp
• Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits
• Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication
• Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
• Pharmacologic methods of contraception should be stable for 1 month prior to Visit 1 and be maintained at same dose during the study

You may not qualify if:

• Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion
• History of hereditary angio-edema, Epilepsy or Parkinson's Disease
• Erythroderma or history of immunodeficiency disorders
• Pregnancy, lactation or patient who is not practicing effective contraception
• History of alcohol and drug abuse within 5 years of screening
• Known hypersensitivity or previous allergic reaction to any of the components of the study medication
• Having a member of the same household in the trial
• Patient has participated in an investigational clinical, surgical, drug or device study within the past 30 days
• Patients who in the opinion of the investigator should not be included in the study for any reason, including inability to follow procedures

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Maccabi Health Clinic

Tel Aviv, Tel Aviv, 6495301, Israel

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 14, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2015-02

Locations

IL (1)