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A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK) on the Head (Face and/or Scalp)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

Thank you

Trial Information

A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK) on the Head (Face and/or Scalp)


Inclusion Criteria:



1. Male or female; aged ≥ 18 years old.

2. Patient who accepts to enter the study by signing written informed consent.

3. Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic,
non-hypertrophic AK, located with or without a contiguous 25cm2 areas on the face
and/or balding scalp.

4. Patient allows biopsy to be performed on selected lesion.

5. Patient agrees to apply the study medication on prescribed treatment area with an
occlusive dressing at least 20 hours per day.

6. Patient agrees photographs to be taken on selected lesion and used as part of the
study data package.

7. Patient in good general health condition (performance status ≤ 2 Eastern Cooperative
Oncology Group (ECOG).

8. Female patient with child-bearing potential must take reliable contraception
method(s) during the participation of the study.

Exclusion Criteria:

1. Patient with recurrent invasive squamous cell carcinoma (SCC).

2. Patient has grossly suspicious or inflamed lymph nodes on physical examination.

3. Patient has evidence of clinically significant or unstable medical conditions.

4. Patient has any skin condition in the treatment area that may be made worse by
treatment.

5. Patient currently uses or had used on the treatment area(s) OTC retinol products,
corticosteroids, cryosurgery, curettage, 5-fluorouracil (5-FU), imiquimod, topical
diclofenac, retinoids, or other topical AK treatments (such as laser abrasion,
dermabrasion, glycolic acids, or chemical peels) 28 days prior to screening visit.

6. Patient had received systemic cancer chemotherapy or immunosuppressant; on the target
evaluation area that psoralen plus UVA therapy, UVB therapy were treated 6 months
prior to screening visit.

7. Patient currently uses or has used prednisone and/or prednisolone (≥ 10 mg or the
equivalent) more than 2 weeks continuously within 12 weeks prior to randomization
visit.

8. Engaging in activities involving excessive or prolonged exposure to sunlight.

9. History of allergy or sensitivity to related compounds or other components of the
investigational product formulation.

10. Woman who is pregnant, lactating or planning to become pregnant during the study.

11. Patient used any investigational drug within 8 weeks prior to the screening visit.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Total clearance rate:

Outcome Description:

The proportion of patients achieving total clearance of AK lesions in the treatment area (in total of 25cm2 area) at 8-week post-EOT visit (scheduled at Week 24 visit) .

Outcome Time Frame:

8-week post-EOT visit (scheduled at Week 24 visit)

Safety Issue:

No

Principal Investigator

Adnan Nasir, MD. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Research Associates

Authority:

United States: Food and Drug Administration

Study ID:

GESRTAKB

NCT ID:

NCT01516515

Start Date:

February 2013

Completion Date:

May 2014

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • AK
  • Keratosis
  • Keratosis, Actinic

Name

Location

Park Avenue DermatologyOrange Park, Florida  32073
North Florida Dermatology AssociateJacksonville, Florida  32204
Wake Research AssociateRaleigh, North Carolina  27612
Dermatology Clinical Resaerch Center of San AntonioSan Antonio, Texas  78229