Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier:
NCT01493921
First received: December 15, 2011
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment. In addition to the high complete response rate (90.0%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100 gel. The result also shows approximately 80% of study subjects had a complete response in phase II clinical trial conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers beneficial therapeutic values in treatment of AK is harmless to the skin as well as high tolerance level displayed by majority of patients.

Condition Intervention Phase
Actinic Keratosis
Drug: SR-T100 gel
Drug: Vehicle gel
Phase 3

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

Resource links provided by NLM:


Further study details as provided by G&E Herbal Biotechnology Co., LTD:

Primary Outcome Measures:
  • Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    SR-T100 clinical application in Actinic Keratosis treatment as direct proportional relationship to lesion size reduction, complete & partial clearance defined consequently as 100% & ≧75% reduction, coordinated toxicity & bio-safety reports supplements additional case study basis & foundation.


Enrollment: 113
Study Start Date: October 2011
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SR-T100 gel
Patient group receiving medication SR-T100 gel with active ingredient under investigation, enrolled subjects randomly assigned to this group to accurately depict statistical significance of the measured outcome.
Drug: SR-T100 gel
Patient will be instructed to self-apply approximately 0.3~0.5g of SR-T100 gel on 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
Active Comparator: Vehicle gel
Patients given placebo with non-SR-T100 ingredients as they are being administered to patients, subjects are under random assignments from patient pool to depict statistically significant outcome measurement.
Drug: Vehicle gel
Patient wil be instructed to self-apply approximately 0.3~0.5g of vehicle gel (without active ingredient)per total of 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493921

Locations
Taiwan
Chiayi Chang Gung Memorial Hospital
Chiayi, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
Chi Mei Medical Center YongKang
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Sponsors and Collaborators
G&E Herbal Biotechnology Co., LTD
Investigators
Principal Investigator: Hamm-Ming Sheu, MD National Cheng-Kung University Hospital
  More Information

Additional Information:
Responsible Party: G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier: NCT01493921     History of Changes
Other Study ID Numbers: GESRTAKA 
Study First Received: December 15, 2011
Last Updated: February 17, 2016
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by G&E Herbal Biotechnology Co., LTD:
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

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on August 23, 2016