Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IVSupportive careActive18 and overMann-Cohen Version 2
NCI-2017-00372, NCT01459666

Trial Description

Summary

Evaluate the efficacy and safety of using aboBTX-A to improve wound healing prior to Mohs

micrographic surgery and reconstruction for skin cancer of the forehead

Further Study Information

  • Outcomes by the Patient and Observer Assessment Scale (POSAS), Visual Analog Scale, and

Patient Satisfaction Survey.

Study consists of 5 clinic visits over approximately 6 months

Eligibility Criteria

Inclusion Criteria:

Have biopsy proven skin cancer on the forehead that is amenable to Mohs surgery

Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to

Mohs surgery with defect size measuring 1.0 cm or greater

If female, not currently pregnant, not currently breastfeeding, no potential for

pregnancy, or if of child-bearing age, agrees to using birth control.

Agrees to not use disallowed concomitant medications (retinoids) and agrees to use

sunscreen in the forehead area for the duration of the study

Exclusion Criteria:

Current or past history of a neuromuscular disease (such as myasthenia gravis,

amyotrophic lateral sclerosis, Eaton-Lambert syndrome)

History of radiation therapy or chemotherapy

History of keloid or other hypertrophic scar formation

Has used botulinum toxin in the forehead area within one year.

Has used any topical retinoids to the forehead area within the past 4 weeks

Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein)

or any previous hypersensitivity to any botulinum toxin A or related product.

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

AboutSkin Dermatology and DermSurgery, PC

  • University Hospitals Cleveland Medical Center
  • Medicis Pharmaceutical Corporation

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01459666

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.