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Clinical Trials/EUCTR2015-003804-21-DE
EUCTR2015-003804-21-DE
Active, not recruiting
Phase 1

Multi-centre, Randomized, Double-blind, Placebo-Controlled Pilot Safety and Efficacy Study of 8 Weeks of Treatment with DFD-07 for Actinic Keratosis of the Face and Scalp

Promius Pharma LLC0 sitesOctober 5, 2015
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ConditionsActinic Keratosis (AK)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Actinic Keratosis (AK)
Sponsor
Promius Pharma LLC
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 5, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Written informed consent has been signed and dated prior to any study related procedure or the initiation of a wash\-out period
  • •Skin type I, II or III according to Fitzpatrick
  • •5\-8 AK mild to moderate grade lesions in an approximately 25 cm2 region of scalp, forehead or face that are non\-hypertrophic and non\-hyperkeratotic
  • •18 years of age or older
  • •Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with a secondary contraceptive option should the patient become sexually active. All women of childbearing potential must have a negative urine pregnancy test (test must have a sensitivity of at least 25 IU/ML for human chorionic gonadotropin) at the Baseline Visit and be willing to be tested throughout the study. A female is considered of childbearing potential unless she is pre\-menarche, postmenopausal with no menses for at least 12 months or surgically sterile. Reliable methods of contraception are hormonal methods or intrauterine devices in use for at least 90 days prior to the Baseline Visit or barrier methods plus spermicide use for at least 14 days prior to the Baseline Visit or a partner who has had a vasectomy at least 3 months prior to the Baseline Visit.
  • •\= 60 days washout from prohibited medications:
  • •o Masoprocol
  • •o 5\-Fluorouracil
  • •o Cyclosporine
  • •o Retinoids

Exclusion Criteria

  • •Known or suspected hypersensitivity to any NSAID or any component of the formulation of the study medication
  • •Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
  • •Significant history (within the past year) of alcohol or drug abuse
  • •Participation in any clinical research study within 60 days of the Baseline Visit.
  • •Pregnancy, lactation or plans to become pregnant
  • •Concomitant use of cosmetics or other topical drug products on or near the selected treatment area. However, the use of topical sun screens is allowed.
  • •Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 2 weeks and within 2 cm of the selected treatment area
  • •Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis, atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism)
  • •Use of sun lamps or tanning beds or booths during the 14 days prior to the Baseline Visit or planned use during the study
  • •Any systemic cancer therapy within 6 months of the Baseline Visit

Outcomes

Primary Outcomes

Not specified

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