Superficial Basal Cell CarcinomaPhase 1/2NCT00604890
Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
A Phase 1/2 study testing API 31510 3% Topical Cream and API 31510 1.5% Topical Cream in people with Superficial Basal Cell Carcinoma, run by BPGbio at 11 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Basal Cell Carcinoma
- What is being tested?
- API 31510 3% Topical Cream and API 31510 1.5% Topical Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2008to Jan 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 adults ≥ 18 years of age
- Primary, histologically confirmed sBCC with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target sBCC lesion suitable for excision
- Histological diagnosis made no more than 4 weeks prior to the screening visit
- Histological biopsy removed 25% or less of the target lesion
- No other dermatological disease in the sBCC target site or surrounding area
- Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period. Willing to refrain from washing the treated area for at least 8 hours following the application of study medication
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- Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
- Laboratory values for the tests listed in the Study Schedule on page 2 within the reference ranges as defined by the central laboratory, or "out of range" test results that are clinically acceptable to the investigator.
- Ability to follow study instructions and likely to complete all study requirements
- Written informed consent obtained, including consent for tissue to be examined and stored by the central dermatopathologist
- Written consent to allow photographs of the target sBCC lesion to be used as part of the study data
- For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy)
Who cannot join
- Pregnant or lactating
- Presence of known or suspected systemic cancer
- Histological evidence of nBCC, SCC, or any other tumor in the biopsy specimen
- Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen
- History of recurrence of the target sBCC lesion
- Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa
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- Concurrent disease or treatment that suppresses the immune system
- Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk
- Known sensitivity to any of the ingredients in the study medication
- Use of a tanning parlor or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the course of the study
- Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
- Use of systemic retinoids within the 6 months prior to the screening period
- Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period
- Use of topical immunomodulators within 2 cm of the target BCC lesion within the 4 weeks prior to the screening period
- Treatment with the following topical agents within the 4 weeks prior to the screening visit: levulanic acid, 5-fluorouracil, coricosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod
- Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the 6 months prior to the screening visit, if the target sBCC lesion is on the face
- Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target sBCC lesion during the 4 weeks prior to the screening visit
- Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the treatment period
- Evidence of current chronic alcohol or drug abuse
- Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit
- In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Scott D. Glazer, M.D., S.C.
Buffalo Grove, Illinois, 60089
Christie Clinic
Champaign, Illinois, 61820
Dermatology Associates and Research
Coral Gables, Florida, 33134
Colorado Medical Research Center
Denver, Colorado, 80210
Burke Pharmaceuticals
Hot Springs, Arkansas, 71913
Education & Research Foundation
Lynchburg, Virginia, 24501
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Skin Surgery Medical Group, Inc.
San Diego, California, 92108
Long Island Skin Cancer and Dermatologic Surgery, PC
Smithtown, New York, 11787
Gwinnett Clinical Research
Snellville, Georgia, 30078
About this study
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. The study population will include one hundred and sixty (160) otherwise healthy male or female adults with one or more histologically confirmed superficial basal cell carcinoma lesions. One target lesion with an area of less than one inch will be designated for study treatment.
- Conditions
- Superficial Basal Cell Carcinoma
- Being tested
- API 31510 3% Topical Cream, API 31510 1.5% Topical Cream, Placebo
- Keywords
- Double-Blind, Placebo, Topical, Treatment, Dose-Ranging, sBCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
API 31510 3% Topical CreamDrug
Topical treatment 3% active cream applied to the lesion
API 31510 1.5% Topical CreamDrug
Topical treatment 1.5% active cream applied to the lesion
PlaceboOther
Topical treatment placebo applied to the lesion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active cream, 3% AM \& PM Receives: Drug: API 31510 3% Topical Cream |
| 2 | Placebo comparator | Placebo cream AM ; 3% active cream PM Receives: Drug: API 31510 3% Topical Cream; Other: Placebo |
| 3 | Placebo comparator | Placebo cream AM; 1.5% active cream PM Receives: Drug: API 31510 1.5% Topical Cream; Other: Placebo |
| 4 | Placebo comparator | Placebo AM and PM Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Response
To determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment).
Measured: 10 weeks
Secondary outcomes (1)
Number of Participants With Partial Response
To determine the number of participants with a partial response, defined as a clinically significant decrease (ie, at least 50%) in the area of the sBCC lesion, computed as the product of the two principal diameters at Week 10 (4 weeks post-treatment)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Superficial Basal Cell CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- BPGbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wilson, MD, Principal investigator, Education and Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604890
- Sponsor's protocol ID
- CTL0108
- Status last verified
- Feb 2019
- First submitted
- 17 Jan 2008
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00604890
- Acronym / sponsor ID
- CTL0108
- Conditions
- Superficial Basal Cell Carcinoma
- Keywords
- Double-Blind, Placebo, Topical, Treatment, Dose-Ranging, sBCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- BPGbioIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. The study population will include one hundred and sixty (160) otherwise healthy male or female adults with one or more histologically confirmed superficial basal cell carcinoma lesions. One target lesion with an area of less than one inch will be designated for study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: API 31510 3% Topical CreamActive cream, 3% AM \& PM |
| 2 | Placebo comparator | Drug: API 31510 3% Topical Cream, Other: PlaceboPlacebo cream AM ; 3% active cream PM |
| 3 | Placebo comparator | Drug: API 31510 1.5% Topical Cream, Other: PlaceboPlacebo cream AM; 1.5% active cream PM |
| 4 | Placebo comparator | Other: PlaceboPlacebo AM and PM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female adults ≥ 18 years of age
- Primary, histologically confirmed sBCC with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target sBCC lesion suitable for excision
- Histological diagnosis made no more than 4 weeks prior to the screening visit
- Histological biopsy removed 25% or less of the target lesion
- No other dermatological disease in the sBCC target site or surrounding area
Key exclusion criteria (21 listed)
- Pregnant or lactating
- Presence of known or suspected systemic cancer
- Histological evidence of nBCC, SCC, or any other tumor in the biopsy specimen
- Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen
- History of recurrence of the target sBCC lesion
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 |
|---|---|---|
| API 31510 3% Topical CreamTopical treatment 3% active cream applied to the lesion | Drug | 1, 2 |
| API 31510 1.5% Topical CreamTopical treatment 1.5% active cream applied to the lesion | Drug | 3 |
| PlaceboTopical treatment placebo applied to the lesion | Other | 2, 3, 4 |
Primary outcome
Number of Participants With Complete Response
Time frame: 10 weeks
To determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment).
1 secondary outcome
Number of Participants With Partial Response
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Wilson, MD principal investigator
Education and Research Foundation
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing API 31510 3% Topical Cream and API 31510 1.5% Topical Cream in people with Superficial Basal Cell Carcinoma, run by BPGbio at 11 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 12 inclusion and 21 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Response (time frame: 10 weeks). 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 28 Feb 2025.