Carcinoma, Basal Cell (BCC)Phase 1NCT02587819

Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment

A Phase 1 study testing Treatment with BSCT in people with Carcinoma, Basal Cell (BCC), run by Biosceptre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Basal Cell (BCC)
What is being tested?: Treatment with BSCT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: No sites listed yet
Study dates: May 2013to Apr 2014
Phase: Phase 1
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;
One primary histologically confirmed BCC lesion, not located on the hand or foot, suitable for surgical excision, with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm (histological diagnosis made no more than 4 weeks prior to the Screening visit.
Willing to refrain from using non-approved lotions or creams on the BCC treatment site and surrounding area during the treatment period and from washing the treated area for at least 8 hours following each application of study medication;
Ability to follow study instructions and likely to complete all study requirements;
Written informed consent obtained, including consent for biopsy tissue to be examined and stored by the central dermatopathologist;
Written consent to allow photographs of the BCC lesion to be used as part of the study data;
For females of childbearing potential, a negative pregnancy test at Screening and use of an acceptable form of birth control.

Who cannot join

Pregnant, lactating, or planning pregnancy during the study;
Presence of known or suspected systemic cancer;
Histological evidence of squamous cell carcinoma (SCC) or any tumor other than BCC in the biopsy specimen;
Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic, or micronodular growth patterns in the biopsy specimen;
Evidence of dermatological disease or confounding skin condition within the 25-cm2 treatment area, eg, SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, or xeroderma pigmentosa;
Concurrent disease or treatment that suppresses the immune system;

Show all 18Show fewer

Chronic medical condition that in the judgment of the investigator 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;
Treatment with systemic chemotherapeutic agents (eg, methotrexate, paclitaxel) within the 6 months prior to the Baseline visit;
Use of systemic retinoids within the 6 months prior to the Baseline visit;
Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the Baseline visit;
Use of topical immunomodulators within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit;
Treatment with topical agents for the treatment of BCC or actinic keratosis within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit:
Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target treatment area during the 4 weeks prior to the Baseline visit;
Clinically significant abnormalities as noted in the screening ECG, physical examination, or laboratory test results;
Evidence of current chronic alcohol or drug abuse which, in the investigator's opinion, might interfere with the subject's adherence to protocol requirements;
Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the Baseline visit;
In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study.

About this study

Official title: An Open-Label Phase 1 Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment When Applied Twice Daily for 28 Days in Male and Female Patients With Basal Cell Carcinoma

This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.

Read the detailed description

The purpose of the trial was to determine the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days in male and female patients with BCC; and to determine the steady-state pharmacokinetics (PK) of the active pharmaceutical ingredient (total sheep Immunoglobulin G [IgG]) when BSCT (anti-nf-P2X7) 10% Ointment is applied twice daily to BCC lesions. This was an open-label, single-arm, multicenter Phase 1 study that enrolled 21 BCC patients.

Conditions: Carcinoma, Basal Cell (BCC)
Being tested: Treatment with BSCT
Medical subject headings: Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment with BSCTDrug
Also called BSCT (anti-nf-P2X7) 10% Ointment
The study product BSCT (anti-nf-P2X7) 10% Ointment was anti-nf-P2X7 (highly purified sheep IgG) in an ointment formulation for topical administration. The formulation contained 10% weight by weight of the active pharmaceutical ingredient in an anhydrous ointment base.
Fifty (50) to 100 mg of product (an amount the size of a small pea) was applied topically twice a day for 28 days to a 25 cm2 area of skin containing a single BCC lesion. The product was to be applied in the morning and in the evening after washing.

Study groups in NCT02587819
Study group	Role	What they receive
Treatment with BSCT	Experimental	21 patients with BCC were treated with BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days. Receives: Drug: Treatment with BSCT

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.
Measured: 8 weeks
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.
Measured: 28 days
Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Apr 2014

First posted27 Oct 2015 (estimated)
Study startMay 2013
Primary completionOct 2013
Study completionApr 2014

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 Carcinoma, Basal Cell (BCC)Studies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02587819
Sponsor's protocol ID: Protocol BSCT-001
Status last verified: Mar 2016
First submitted: 21 Oct 2015
Last updated: 14 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Carcinoma, Basal Cell (BCC) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Phase 1 Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment When Applied Twice Daily for 28 Days in Male and Female Patients With Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT02587819
Acronym / sponsor ID: Protocol BSCT-001
Conditions: Carcinoma, Basal Cell (BCC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: BiosceptreIndustry (pharma, biotech, devices)
Collaborators: TKL Research, Inc.
Study start: May 2013
Primary completion: Oct 2013 (actual)
Study completion: Apr 2014 (actual)
First posted: 27 Oct 2015 (estimated)
Results: Posted 15 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment with BSCT	Experimental	Drug: Treatment with BSCT21 patients with BCC were treated with BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female adults ≥ 18 years of age;
One primary histologically confirmed BCC lesion, not located on the hand or foot, suitable for surgical excision, with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm (histological diagnosis made no more than 4 weeks prior to the Screening visit.
Willing to refrain from using non-approved lotions or creams on the BCC treatment site and surrounding area during the treatment period and from washing the treated area for at least 8 hours following each application of study medication;
Ability to follow study instructions and likely to complete all study requirements;
Written informed consent obtained, including consent for biopsy tissue to be examined and stored by the central dermatopathologist;

Key exclusion criteria (18 listed)

Pregnant, lactating, or planning pregnancy during the study;
Presence of known or suspected systemic cancer;
Histological evidence of squamous cell carcinoma (SCC) or any tumor other than BCC in the biopsy specimen;
Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic, or micronodular growth patterns in the biopsy specimen;
Evidence of dermatological disease or confounding skin condition within the 25-cm2 treatment area, eg, SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, or xeroderma pigmentosa;

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
Treatment with BSCTAlso: BSCT (anti-nf-P2X7) 10% OintmentThe study product BSCT (anti-nf-P2X7) 10% Ointment was anti-nf-P2X7 (highly purified sheep IgG) in an ointment formulation for topical administration. The formulation contained 10% weight by weight of the active pharmaceutical ingredient in an anhydrous ointment base. Fifty (50) to 100 mg of product (an amount the size of a small pea) was applied topically twice a day for 28 days to a 25 cm2 area of skin containing a single BCC lesion. The product was to be applied in the morning and in the evening after washing.	Drug	Treatment with BSCT

Primary outcome

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 8 weeks
Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
Time frame: 28 days
To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.
Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
Time frame: 8 weeks
The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).

Results and safety

Results posted to the registry on 15 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With BSCT	21	19

Primary outcome: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Time frame: 8 weeks. Number. Unit: participants

Measure	Treatment With BSCT n = 21
Subjects with any Serious Adverse Events	1
Subjects with Treatment-emergent Adverse Event(s)	12

Population analysed: All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.

Primary outcome: Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.

Time frame: 28 days. Median (Full Range). Unit: ng/ml

Measure	Treatment With BSCT n = 21
Pre-dose - Baseline visit	NA (NA to NA)
Pre dose - Visit 5	NA (NA to 24.68)
Pre dose - Visit 6	NA (NA to 22.85)
1 hour post dose - Visit 6	NA (NA to 7.08)
2 hours post dose - Visit 6	NA (NA to NA)
4 hours post dose - Visit 6	NA (NA to NA)

Population analysed: At all timepoints, the serum concentration of sheep IgG was too low to be quantified in most of the subjects. One subject had measurable sheep IgG at 1 hr post dose at Visit 6 (EOT) and 3 other subjects had measurable sheep IgG at predose timepoints. In outcome measure below NA represents readings less than lower limit of quantification.

Primary outcome: Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.

Time frame: 8 weeks. Number. Unit: percentage of subjects

Measure	Treatment With BSCT n = 21
Subjects with anti sheep IgG at screening	42.9
Subjects with anti sheep IgG at Baseline	38.1
Subjects with anti sheep IgG at visit 6	50
Subjects with anti sheep IgG at visit 8	52.6

Population analysed: Anti sheep IgG antibody titres were measured from 21 subjects at screening and baseline, 20 subjects at Visit 6 (Day 29 EOT) and 19 subjects at Visit 8 (Day 57 follow up). The percentage of patients with detectable anti sheep antibodies is reported.

Adverse events

Time frame: 8 weeks (28 day treatment period and 28 day follow up period).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With BSCT	1 of 21 (4.8%)	12 of 21 (57.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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.

Angus Gidely-Baird, PhD study director

Scientific Director - Biosceptre

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment with BSCT in people with Carcinoma, Basal Cell (BCC), run by Biosceptre.

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 7 inclusion and 18 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 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.

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 15 Mar 2016). 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?

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02587819.

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 14 Apr 2016.