Reduction in Hypertrophic Skin ScarringPhase 2NCT01346969

Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

A Phase 2 study testing EXC 001 in people with Reduction in Hypertrophic Skin Scarring, run by Pfizer at 12 sites in United States.

Completed

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

Official record

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Trial summary

The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Reduction in Hypertrophic Skin Scarring
What is being tested?: EXC 001
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 12 sitesUnited States
Study dates: 1 Jun 2011to 16 Apr 2012
Phase: Phase 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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have previous had breast surgery resulting in unacceptable scars.
Subject has chosen to have breast scars revised.
Subject must not be pregnant or lactating.

Who cannot join

Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or lactating.
Participation in another clinical trial within 30 days prior to the start of the study.
Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for the study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Mark L. Jewell,MD Surgery Center
Eugene, Oregon, 97401
Altus Research
Lake Worth, Florida, 33461
Bayside Ambulatory Center
Miami, Florida, 33133
Aesthetic Plastic Surgery Miami
Miami, Florida, 33146
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
BAXTER Plastic Surgery
Mountlake Terrace, Washington, 98043
Skin Deep Laser Medical Spa
Pasadena, California, 91105
Endeavor Clinical Trials,P.A.
San Antonio, Texas, 78229
Texas Plastic Surgery
San Antonio, Texas, 78240-1670
Body Aesthetic Plastic Surgery
St Louis, Missouri, 63141
Connall Consmetic Surgery
Tualatin, Oregon, 97062
Bright Health Physicans Plastic Surgery and Aesthetic Medicine
Whittier, California, 90602

Other trials in United States

About this study

Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)

Conditions: Reduction in Hypertrophic Skin Scarring
Being tested: EXC 001
Keywords: Skin scarring, cicatrix, breast scar
Medical subject headings: Cicatrix

What participants receive

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

EXC 001Drug
Single-dose administered by injection four different times
EXC 001Drug
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
EXC 001Drug
Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2
EXC 001Drug
Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3

Study groups in NCT01346969
Study group	Role	What they receive
Group 1	Active comparator	Not described Receives: Drug: EXC 001
Group 2	Placebo comparator	Not described Receives: Drug: EXC 001
Group 3	Placebo comparator	Not described Receives: Drug: EXC 001
Group 4	Placebo comparator	Not described Receives: Drug: EXC 001

What is being measured

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

Physician Observer Scar Assessment Score at Week 24
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Measured: Week 24

Secondary outcomes (5)

Physician Observer Scar Assessment Score
Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Measured: Week 11, 18
Expert Panel Scar Assessment Score
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.
Measured: Week 11, 18, 24
Subject Observer Scar Assessment Score
Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.
Measured: Week 24
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Measured: Week 24
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Measured: Week 24

Timeline

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

1 Jun 201116 Apr 2012

First posted4 May 2011 (estimated)
Study start1 Jun 2011
Primary completion16 Apr 2012
Study completion16 Apr 2012

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 Reduction in Hypertrophic Skin ScarringStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01346969
Sponsor's protocol ID: EXC 001-204
Other IDs: B5301004
Status last verified: Aug 2021
First submitted: 1 May 2011
Last updated: 9 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)
ClinicalTrials.gov ID: NCT01346969
Acronym / sponsor ID: EXC 001-204
Conditions: Reduction in Hypertrophic Skin Scarring
Keywords: Skin scarring, cicatrix, breast scar
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Jun 2011 (actual)
Primary completion: 16 Apr 2012 (actual)
Study completion: 16 Apr 2012 (actual)
First posted: 4 May 2011 (estimated)
Results: Posted 9 Sep 2021

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group 1	Active comparator	Drug: EXC 001
Group 2	Placebo comparator	Drug: EXC 001
Group 3	Placebo comparator	Drug: EXC 001
Group 4	Placebo comparator	Drug: EXC 001

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects must have previous had breast surgery resulting in unacceptable scars.
Subject has chosen to have breast scars revised.
Subject must not be pregnant or lactating.

Key exclusion criteria (3 listed)

Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or lactating.
Participation in another clinical trial within 30 days prior to the start of the study.
Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for the study.

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
EXC 001Single-dose administered by injection four different times	Drug	Group 1
EXC 001Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1	Drug	Group 2
EXC 001Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2	Drug	Group 3
EXC 001Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3	Drug	Group 4

Primary outcome

Physician Observer Scar Assessment Score at Week 24
Time frame: Week 24
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.

5 secondary outcomes

Physician Observer Scar Assessment Score
Time frame: Week 11, 18
Expert Panel Scar Assessment Score
Time frame: Week 11, 18, 24
Subject Observer Scar Assessment Score
Time frame: Week 24
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
Time frame: Week 24
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
Time frame: Week 24

Results and safety

Results posted to the registry on 9 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EXC 001 (PF-06473871) 5 mg/cm	28	26
EXC 001 (PF-06473871) 2 mg/cm and Placebo	14	14
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo	13	10
EXC 001 (PF-06473871) 5 mg/cm and Placebo	13	12

Primary outcome: Physician Observer Scar Assessment Score at Week 24

Time frame: Week 24. Mean (Standard Deviation). Unit: units on a scale

Measure	EXC 001 (PF-06473871) 5 mg/cm n = 26	EXC 001 (PF-06473871) 2 mg/cm and Placebo n = 14	EXC 001 (PF-06473871) 0.8 mg/cm and Placebo n = 10	EXC 001 (PF-06473871) 5 mg/cm and Placebo n = 12
Overall Opinion	0.0 (1.92)	-0.5 (2.31)	0.8 (1.87)	-0.3 (1.97)
Vascularity	0.0 (1.70)	-0.6 (1.91)	0.9 (1.52)	-0.2 (1.64)
Pigmentation	-0.3 (1.41)	-0.4 (2.10)	0.7 (1.42)	-0.3 (1.36)
Thickness	0.2 (2.41)	-0.6 (2.38)	0.8 (2.04)	-0.2 (1.90)
Relief	0.0 (2.24)	-0.4 (1.95)	0.7 (2.36)	-0.2 (1.90)
Pliability	0.2 (1.99)	-0.6 (2.27)	0.6 (1.71)	-0.4 (1.62)
Surface Area	0.1 (1.75)	-0.4 (2.85)	0.6 (1.90)	-0.1 (2.15)
Composite Score	0.2 (10.53)	-3.1 (12.60)	4.3 (9.76)	-1.3 (8.67)

EXC 001 (PF-06473871) 5 mg/cm: LS Mean: 0.0 (95% CI -0.8 to 0.8), p = 1.000, Mixed Models Analysis
EXC 001 (PF-06473871) 5 mg/cm: LS Mean: 0.0 (95% CI -0.7 to 0.7), p = 1.000, Mixed Models Analysis
EXC 001 (PF-06473871) 5 mg/cm: LS Mean: -0.3 (95% CI -1.0 to 0.4), p = 0.391, Mixed Models Analysis

Population analysed: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies participants who were evaluable for this outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EXC 001 (PF-06473871) 5 mg/cm	0 of 27 (0%)	13 of 27 (48.1%)	Not reported
EXC 001 (PF-06473871) 2 mg/cm and Placebo	0 of 14 (0%)	2 of 14 (14.3%)	Not reported
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo	0 of 13 (0%)	2 of 13 (15.4%)	Not reported
EXC 001 (PF-06473871) 5 mg/cm and Placebo	0 of 13 (0%)	3 of 13 (23.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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.

Pfizer CT.gov Call Center study director

Pfizer

12 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 EXC 001 in people with Reduction in Hypertrophic Skin Scarring, run by Pfizer at 12 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 3 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 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

Yes. Results are posted in the registry (first posted 9 Sep 2021). 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?

Physician Observer Scar Assessment Score at Week 24 (time frame: Week 24). 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 NCT01346969.

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 Sep 2021.