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

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

SR-T100 gel

Vehicle gel

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring 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

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.
Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs.
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.
Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
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.
Patient is known to be hypersensitive to the study medication.
Female who is pregnant, breast fed or considers of becoming pregnant while on the study.
Patient had used of any investigational drug within the past 30 days before enrollment.

Sites / Locations

Chiayi Chang Gung Memorial Hospital
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital
Chi Mei Medical Center YongKang
National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SR-T100 gel

Vehicle gel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

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.

Full Information

NCT ID

NCT01493921

First Posted

December 15, 2011

Last Updated

February 17, 2016

Sponsor

G&E Herbal Biotechnology Co., LTD

1. Study Identification

Unique Protocol Identification Number

NCT01493921

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

G&E Herbal Biotechnology Co., LTD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SR-T100 gel

Arm Type

Experimental

Arm Description

Arm Title

Vehicle gel

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

SR-T100 gel

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Vehicle gel

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment

Description

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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: 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. Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs. 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. Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation. 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. Patient is known to be hypersensitive to the study medication. Female who is pregnant, breast fed or considers of becoming pregnant while on the study. Patient had used of any investigational drug within the past 30 days before enrollment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamm-Ming Sheu, MD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chiayi Chang Gung Memorial Hospital

City

Chiayi

Country

Taiwan

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

Country

Taiwan

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

Country

Taiwan

Facility Name

Chi Mei Medical Center YongKang

City

Tainan

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

Country

Taiwan

12. IPD Sharing Statement

Links:

URL

http://www.geherbs.com.tw/index.php?option=module&lang=cht&task=pageinfo&id=72&index=3

Description

Related Info

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

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