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A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis


Phase 3
20 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

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Trial Information

A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis


The primary objective of this study is to demonstrate a clinically significant outcome
involving SR-T100 topical gel developed against skin lesions such as AK. Furthermore,
evaluation of SR-T100 efficacy & tolerability in treating AK lesions are developed as
secondary objective in this clinical study. Patients with at least two clinically visible,
discrete, non-hyperkeratotic, non-hypertrophic AK lesions on the arms, shoulder, chest, face
and or scalp and at least one lesion of greater than or equal to 4mm in diameter within a
total of 25 cm squared contiguous or non-contiguous treatment are expected to be enrolled.
Candidate pool is then divided into two groups with random assignments of treatment group or
placebo group. This randomization scheme will be generated by biostatistics and produced by
a computer software program that incorporates a standard procedure for generating random
probabilities. Study procedures include laboratory testings, analytical readings as well as
clinical assessment practices for treatment efficacy and safety evaluations.


Inclusion Criteria:



Male or female is 20 years of age or above and patient has at least two clinically
visible, discrete, non hyperkeratotic, hypertrophic AK lesions located within a 25 cm
squared contiguous or non contiguous treatment area including the arms, shoulder, chest,
face and scalp 3 patient has at least one histological confirmed actinic keratosis lesion
of greater or equal to 4 mm in diameter within the selected treatment area.

Exclusion Criteria:

1. Patient has any dermatological disease and condition, such as atopic dermatitis,
basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma,
or other possible confounding skin conditions in the treatment or surrounding area
within 5cm distances from treatment area.

2. Patient had used the following treatments within 4 weeks prior to the study treatment
initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic
drugs.

3. Patient treated with topical 5 FU, diclofenac gel, imiquimod, corticosteroids,
retinoids, masoprocol on the treatment area within 4 weeks prior to the study
treatment initiation.

4. Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy,
surgical excision on the treatment area within 4 weeks prior to the study treatment
initiation.

5. Patient had received any of the following treatments on the treatment area in 6
months before study treatment initiation begins, such as psoralen plus UVA therapy,
UVB therapy, laser abrasion, dermabrasion chemical peel.

6. Patient is known to be hypersensitive to the study medication.

7. Female who is pregnant, breast fed or considers of becoming pregnant while on the
study.

8. Patient had used of any investigational drug within the past 30 days before
enrollment.

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:

Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis

Outcome Description:

The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment. The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups. The complete clearance is defined as the absence of visible or palpable AK lesions in the treatment area

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Hamm-Ming Sheu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cheng-Kung University Hospital

Authority:

Taiwan : Food and Drug Administration

Study ID:

GESRTAKA

NCT ID:

NCT01493921

Start Date:

October 2011

Completion Date:

April 2014

Related Keywords:

  • Actinic Keratosis
  • SR-T100 Clinical treatment against Actinic Keratosis
  • Actinic keratosis skin lesion treatment with SR-T100 gel
  • Skin lesion treatment with SR-T100 gel
  • SR-T100 gel treatment against skin lesion
  • Clinical efficacy study of SR-T100 gel
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

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