Acneiform RashPhase 2EGFR'INCT01256437
Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash
A Phase 2 study testing Threolone ointment, ointment Synthomycine and Aqua cream in people with Acneiform Rash, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acneiform Rash
- What is being tested?
- Threolone ointment, ointment Synthomycine and Aqua cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Mar 2017
- 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
- Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab.
Who cannot join
- Patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation.
- Known hypersensitivity to ointment Synthomycine or to Threolone.
- Patients presented with cutaneous rash during the 2 weeks prior to study initiation
Trial locations and contacts
1 site in 1 country.
Israel1 site
Davidoff Center, Rabin Medical Center, Beilinson
Petah Tikva, Israel, 49100
About this study
Official title: Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
Read the detailed description
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
- Conditions
- Acneiform Rash
- Being tested
- Threolone ointment, ointment Synthomycine, Aqua cream
- Keywords
- Acneiform eruption, papulopustular, EGFR, cetuximab, erlotinib, gefitinib, panitumumab, eruption secondary to treatment with either cetuximab
- Medical subject headings
- Acneiform Eruptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threolone ointmentDrug
ointment once daily for 1 month
ointment SynthomycineDrug
ointment once daily for 1 month
Aqua creamDrug
ointment once daily for 1 month
| Study group | Role | What they receive |
|---|---|---|
| ointment Threolone | Experimental | Treatment with topical application of combined anti inflammatory and anti bacterial agent. Receives: Drug: Threolone ointment; Drug: ointment Synthomycine; Drug: Aqua cream |
| ointment Synthomycine | Active comparator | ointment once daily for 1 month Receives: Drug: ointment Synthomycine; Drug: Aqua cream |
| Aqua cream | Placebo comparator | Not described Receives: Drug: Aqua cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
Measured: 3 years
Secondary outcomes (1)
Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acneiform RashStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, iris amitay, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256437
- Sponsor's protocol ID
- 6046
- Acronym
- EGFR'I
- Status last verified
- May 2017
- First submitted
- 7 Dec 2010
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Lee JE, Lee SJ, Lee HJ, Lee JH, Lee KH. Severe acneiform eruption induced by cetuximab (Erbitux). Yonsei Med J. 2008 Oct 31;49(5):851-2. doi: 10.3349/ymj.2008.49.5.851.
PubMed 18972607Lacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1351-7. doi: 10.1200/JCO.2008.21.7828. Epub 2010 Feb 8.
PubMed 20142600
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash
- ClinicalTrials.gov ID
- NCT01256437
- Acronym / sponsor ID
- EGFR'I / 6046
- Conditions
- Acneiform Rash
- Keywords
- Acneiform eruption, papulopustular, EGFR, cetuximab, erlotinib, gefitinib, panitumumab, eruption secondary to treatment with either cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Dec 2010 (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.
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
Detailed description
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ointment Threolone | Experimental | Drug: Threolone ointment, Drug: ointment Synthomycine, Drug: Aqua creamTreatment with topical application of combined anti inflammatory and anti bacterial agent. |
| ointment Synthomycine | Active comparator | Drug: ointment Synthomycine, Drug: Aqua creamointment once daily for 1 month |
| Aqua cream | Placebo comparator | Drug: Aqua cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab.
Key exclusion criteria (3 listed)
- Patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation.
- Known hypersensitivity to ointment Synthomycine or to Threolone.
- Patients presented with cutaneous rash during the 2 weeks prior to study initiation
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 |
|---|---|---|
| Threolone ointmentointment once daily for 1 month | Drug | ointment Threolone |
| ointment Synthomycineointment once daily for 1 month | Drug | ointment Synthomycine, ointment Threolone |
| Aqua creamointment once daily for 1 month | Drug | Aqua cream, ointment Synthomycine, ointment Threolone |
Primary outcome
Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
Time frame: 3 years
1 secondary outcome
Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms
Time frame: 3 years
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 9 May 2017.
- Background: PubMed 18972607Lee JE, Lee SJ, Lee HJ, Lee JH, Lee KH. Severe acneiform eruption induced by cetuximab (Erbitux). Yonsei Med J. 2008 Oct 31;49(5):851-2. doi: 10.3349/ymj.2008.49.5.851.
- Background: PubMed 20142600Lacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1351-7. doi: 10.1200/JCO.2008.21.7828. Epub 2010 Feb 8.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Threolone ointment, ointment Synthomycine and Aqua cream in people with Acneiform Rash, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 3 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms. (time frame: 3 years). 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 NCT01256437, which also lists 2 linked publications.
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 9 May 2017.