ScarPhase 4NCT05271708
Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery
A Phase 4 study testing Fespixon cream in people with Scar, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
The aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Scar
- What is being tested?
- Fespixon cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2022to 30 Nov 2022
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged over 20 years old (inclusive).
- Subjects with linear scar in neck or abdomen following elective surgery, including thyroid and parathyroid surgery, excision of neck mass, caesarean section, trans-abdominal hysterectomy, trans-abdominal myomectomy or any neck or abdominal surgeries which can be managed by primary closure of clean surgical wounds.
Who cannot join
- Subjects who have previous neck or abdominal trauma that will affect the surgical incision site.
- After radiation therapy for cervical/abdominal cancer, or previous medical history with chemo-therapy or targeted therapy for any reason.
- Laboratory values at Screening of:
- Note: The investigator will decide which of the following laboratory tests should be performed considering the condition of the subject.
- Albumin < 2.5 g/dL (for subjects with severe malnutrition)
- HbA1c >12.0% (for subjects with severe diabetes)
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- Liver function test [ aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
- Renal function test [Serum Creatinine] > 2x the upper limit of normal
- Subject is currently receiving immunosuppressant or systemic corticosteroids.
- Has any other factor which may, in the opinion of the investigator, compromise participation in the study.(Including subjects with medical history of keloid or hypertrophic scar).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, National Defense Medical Center
Taipei, 114
About this study
The aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.
Read the detailed description
Methods: This study was designed as a prospective, double-blind, placebo-controlled trial involving 50 patients with linear scars. Bounded by the midpoint of the scar, each patient received a topical scar formulation consisting of fespixon cream on one side of scar, and placebo cream on the other side of scar. Treatment was given twice a day for 84 days. Assessments of the scars were performed at visit 1, 2, 3 following the onset of topical application using three methods: a clinical assessment using the Vancouver Scar Scale/ modified Vancouver Scar Scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire.
- Conditions
- Scar
- Being tested
- Fespixon cream, Placebo Cream
- Keywords
- Fespixon, Thyroidectomy, caesarean section, Scar, ON101
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fespixon creamDrug
Also called ON101 cream
Bounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days.
Placebo CreamDrug
Bounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| Fespixon cream | Experimental | Fespixon cream contains 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) with appearance in yellow-green to light green color. Fespixon cream will be applied twice daily for up to 12 weeks to the linear wound. Receives: Drug: Fespixon cream |
| Placebo Cream | Placebo comparator | Placebo cream with appearance in yellow-green to light green color, same appearance as Fespixon cream, will be applied twice daily for up to 12 weeks to the linear wound. Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators
The VSS scores, assessed by 3 blind evaluators, changed from Day 1 to Week 12 will be used as an objective evidence.
Measured: 12-week
Secondary outcomes (12)
mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator
The mVSS scores, assessed by a Principal Investigator, changed from Day 1 to Week 12 will be used as an auxiliary evidence.
Measured: 12-week
Hue feature-Red values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
Hue feature-Green values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
Hue feature-Blue values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
CIELab-lightness values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
CIELab-a values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
CIELab-b values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12
- Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline.
NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio
NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin
Measured: 12-week
VAS (Visual Analogue Scale) score at Week 12
VAS score (on a scale from 0 to 10) at Week 12 are used to present the satisfaction of participants. Zero means participants feel "not at all satisfied" and 10 means participants feel "completely satisfied".
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start5 Jan 2022
- Primary completion17 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The patient's wound was treated with a placebo or therapeutic ointment on the right side and a placebo or therapeutic ointmenton the left side.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao-Cheng Liu, National Defense Medical Center, Taiwan
- Investigators
- Shao-Cheng Liu, PhD, Principal investigator, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271708
- Sponsor's protocol ID
- B202105176
- Other IDs
- B202105176L
- Status last verified
- Dec 2022
- First submitted
- 15 Feb 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05271708
- Acronym / sponsor ID
- B202105176
- Conditions
- Scar
- Keywords
- Fespixon, Thyroidectomy, caesarean section, Scar, ON101
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- 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 aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.
Detailed description
Methods: This study was designed as a prospective, double-blind, placebo-controlled trial involving 50 patients with linear scars. Bounded by the midpoint of the scar, each patient received a topical scar formulation consisting of fespixon cream on one side of scar, and placebo cream on the other side of scar. Treatment was given twice a day for 84 days. Assessments of the scars were performed at visit 1, 2, 3 following the onset of topical application using three methods: a clinical assessment using the Vancouver Scar Scale/ modified Vancouver Scar Scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patient's wound was treated with a placebo or therapeutic ointment on the right side and a placebo or therapeutic ointmenton the left side.
| Arm | Type | Receives |
|---|---|---|
| Fespixon cream | Experimental | Drug: Fespixon creamFespixon cream contains 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) with appearance in yellow-green to light green color. Fespixon cream will be applied twice daily for up to 12 weeks to the linear wound. |
| Placebo Cream | Placebo comparator | Drug: Placebo CreamPlacebo cream with appearance in yellow-green to light green color, same appearance as Fespixon cream, will be applied twice daily for up to 12 weeks to the linear wound. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged over 20 years old (inclusive).
- Subjects with linear scar in neck or abdomen following elective surgery, including thyroid and parathyroid surgery, excision of neck mass, caesarean section, trans-abdominal hysterectomy, trans-abdominal myomectomy or any neck or abdominal surgeries which can be managed by primary closure of clean surgical wounds.
Key exclusion criteria (10 listed)
- Subjects who have previous neck or abdominal trauma that will affect the surgical incision site.
- After radiation therapy for cervical/abdominal cancer, or previous medical history with chemo-therapy or targeted therapy for any reason.
- Laboratory values at Screening of:
- Note: The investigator will decide which of the following laboratory tests should be performed considering the condition of the subject.
- Subject is currently receiving immunosuppressant or systemic corticosteroids.
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 |
|---|---|---|
| Fespixon creamAlso: ON101 creamBounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days. | Drug | Fespixon cream |
| Placebo CreamBounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days. | Drug | Placebo Cream |
Primary outcome
VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators
Time frame: 12-week
The VSS scores, assessed by 3 blind evaluators, changed from Day 1 to Week 12 will be used as an objective evidence.
12 secondary outcomes
mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator
Time frame: 12-week
Hue feature-Red values via digital analysis at Day 1 and Week 12
Time frame: 12-week
Hue feature-Green values via digital analysis at Day 1 and Week 12
Time frame: 12-week
Hue feature-Blue values via digital analysis at Day 1 and Week 12
Time frame: 12-week
CIELab-lightness values via digital analysis at Day 1 and Week 12
Time frame: 12-week
CIELab-a values via digital analysis at Day 1 and Week 12
Time frame: 12-week
CIELab-b values via digital analysis at Day 1 and Week 12
Time frame: 12-week
Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12
Time frame: 12-week
Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12
Time frame: 12-week
Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12
Time frame: 12-week
Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12
Time frame: 12-week
VAS (Visual Analogue Scale) score at Week 12
Time frame: 12-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 28 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Shao-Cheng Liu, PhD principal investigator
Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fespixon cream in people with Scar, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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 2 inclusion and 10 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 Dec 2022. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators (time frame: 12-week). 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 Dec 2022.