Actinic KeratosisPhase 2NCT01516515
Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis
A Phase 2 study testing SR-T100 with 2.3% of SM in people with Actinic Keratosis, run by G&E Herbal Biotechnology Co., LTD at 8 sites in United States.
Trial summary
This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- SR-T100 with 2.3% of SM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2013to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female; aged ≥ 18 years old.
- Patient who accepts to enter the study by signing written informed consent.
- Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.
- Patient allows biopsy to be performed on selected lesion.
- Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.
- Patient agrees photographs to be taken on selected lesion and used as part of the study data package.
- Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
- Sexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.
Who cannot join
- Patient with recurrent invasive squamous cell carcinoma (SCC).
- Patient has grossly suspicious or inflamed lymph nodes on physical examination.
- Patient has evidence of clinically significant or unstable medical conditions.
- Patient has any skin condition in the treatment area that may be made worse by treatment.
- 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.
- 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.
Show all 11Show fewer
- 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.
- Engaging in activities involving excessive or prolonged exposure to sunlight.
- History of allergy or sensitivity to related compounds or other components of the investigational product formulation.
- Woman who is pregnant, lactating or planning to become pregnant during the study.
- Patient used any investigational drug within 8 weeks prior to the screening visit.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Suzanne Bruce and Associates,P.A. The Center for Skin Research
Katy, Texas, 77056
IMMUNOe International Research Centers
Longmont, Colorado, 80501
The Education & Research Foundation, Inc
Lynchburg, Virginia, 24501
Pflugerville Dermatology Clinical Research
Pflugerville, Texas, 78660
Contour Dermatology & Cosmetic Surgery Center
Rancho Mirage, California, 92270
Premier Clinical Research
Spokane, Washington, 99204
Atlantic Clinical Research Collaborative
West Palm Beach, Florida, 33406
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Official title: A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)
This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).
- Conditions
- Actinic Keratosis
- Being tested
- Vehicle gel, SR-T100 with 2.3% of SM
- Keywords
- Actinic Keratosis, AK
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle gelDrug
placebo
SR-T100 with 2.3% of SMDrug
Also called SR-T100
2.3% of SM in Solanum undatum plant extract
| Study group | Role | What they receive |
|---|---|---|
| placebo, gel | Placebo comparator | placebo comparator Receives: Drug: Vehicle gel |
| SR-T100 with 2.3% of SM, gel | Active comparator | 2.3% of SM in Solanum undatum plant extract Receives: Drug: SR-T100 with 2.3% of SM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clearance rate:
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) .
Measured: 8-week post-EOT visit (scheduled at Week 24 visit)
Secondary outcomes (1)
Partial clearance rate
The proportion of patients achieving ≥ 75% total clinically assessed AK lesion counts out of all target lesions in the treatment area (in total of 25cm2 area) at the post-EOT visit (8 weeks after EOT visit).
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- G&E Herbal Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516515
- Sponsor's protocol ID
- GESRTAKB
- Status last verified
- Dec 2018
- First submitted
- 17 Jan 2012
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)
- ClinicalTrials.gov ID
- NCT01516515
- Acronym / sponsor ID
- GESRTAKB
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, AK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- G&E Herbal Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo, gel | Placebo comparator | Drug: Vehicle gelplacebo comparator |
| SR-T100 with 2.3% of SM, gel | Active comparator | Drug: SR-T100 with 2.3% of SM2.3% of SM in Solanum undatum plant extract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female; aged ≥ 18 years old.
- Patient who accepts to enter the study by signing written informed consent.
- Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.
- Patient allows biopsy to be performed on selected lesion.
- Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.
Key exclusion criteria (11 listed)
- Patient with recurrent invasive squamous cell carcinoma (SCC).
- Patient has grossly suspicious or inflamed lymph nodes on physical examination.
- Patient has evidence of clinically significant or unstable medical conditions.
- Patient has any skin condition in the treatment area that may be made worse by treatment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vehicle gelplacebo | Drug | placebo, gel |
| SR-T100 with 2.3% of SMAlso: SR-T1002.3% of SM in Solanum undatum plant extract | Drug | SR-T100 with 2.3% of SM, gel |
Primary outcome
Total clearance rate:
Time frame: 8-week post-EOT visit (scheduled at Week 24 visit)
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) .
1 secondary outcome
Partial clearance rate
Time frame: 24 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR-T100 with 2.3% of SM in people with Actinic Keratosis, run by G&E Herbal Biotechnology Co., LTD at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total clearance rate: (time frame: 8-week post-EOT visit (scheduled at Week 24 visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.