Hypertrophic ScarsPhase 2NCT07891416
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
A Phase 2 study testing ETD-001 gel in people with Hypertrophic Scars, run by Etern Therapeutics Wuxi Limited at 1 site in China.
Trial summary
A randomized, double-blind, placebo-controlled multiple dosing study to evaluate the preliminary efficacy and safety of ETD-001 gel for hypertrophic scars. Subjects will be assigned to 3 groups: ETD-001 Dose Group 1, ETD-001 Dose Group 2, and placebo group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- ETD-001 gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2027to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 1. Participants with hypertrophic scars aged ≥18 years and <65 years at randomization, with no restriction on sex.
- 2. Subjects experienced burn, surgery, trauma or other events within 6 months prior to screening; the wound has healed and scar formation (linear or extensively growing hypertrophic scar) confirmed by investigator assessment.
- 3. The target treatment scar selected upon investigator judgment meets the morphological characteristics of hypertrophic scar: the scar rises above normal skin tissue, confined within the lesion area, and the subject reports no obvious spontaneous scar regression recently.
- 4. The modified Vancouver Scar Scale (mVSS) score of the target scar is between 7 and 15, inclusive.
Who cannot join
- 1. The target scar is located on the head and face, both hands, genitals, or areas with severely limited joint movement.
- 2. Subjects who received systemic or intralesional corticosteroids (triamcinolone acetonide, betamethasone, etc.), immunosuppressants, chemotherapeutic agents (5-fluorouracil, bleomycin, mitomycin C, etc.), biological products (botulinum toxin, hyaluronidase, interferon, etc.) for scar treatment within 2 months prior to dosing.
- 3. Subjects who received scar treatments including laser, radiotherapy, cryotherapy, compression therapy within 2 months prior to dosing.
- 4. Subjects with local infection on the hypertrophic target scar at screening, or with systemic infection.
- 5. Subjects diagnosed with keloid, atrophic scar or scar carcinoma. 6. Subjects with previous or current clinically significant diseases including but not limited to diseases of digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, immune, neuropsychiatric, hematological systems, or history of malignant tumors, who are judged by the investigator to be unsuitable for enrollment.
- Subjects with syphilis (positive treponema pallidum antibody), AIDS (positive HIV antibody), active hepatitis C (positive HCV antibody), or active hepatitis B (positive HBsAg). Non-active HBsAg carriers and hepatitis B patients treated with stable condition (HBV DNA < 500 IU/mL) are eligible for enrollment; HBV DNA will be monitored periodically per investigator's recommendation during the study. Subjects with positive HCV-Ab may be enrolled if HCV RNA is negative, and HCV RNA will be monitored periodically per investigator's recommendation during the study.
- Uncontrolled hypertension within 1 month prior to screening (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg in sitting position despite optimal antihypertensive therapy).
- Any of the following laboratory abnormalities at screening: ALT or AST > 3 × ULN; total serum bilirubin > 1.5 × ULN; serum creatinine > 1.5 × ULN; creatinine clearance < 60 mL/min; hemoglobin (Hb) < 80 g/L; platelet (PLT) <75.0 ×10⁹/L; fasting plasma glucose (FPG) ≥7.0 mmol/L (126 mg/dL); HbA1c ≥6.5%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
yan liu Chief Physician, 86-18917762771, rjliuyan@126.com
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Preliminary Efficacy and Safety of ETD-001 Gel for the Treatment of Hypertrophic Scars
A randomized, double-blind, placebo-controlled multiple dosing study to evaluate the preliminary efficacy and safety of ETD-001 gel for hypertrophic scars. Subjects will be assigned to 3 groups: ETD-001 Dose Group 1, ETD-001 Dose Group 2, and placebo group.
- Conditions
- Hypertrophic Scars
- Being tested
- ETD-001 gel, Placebo
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETD-001 gelDrug
Topical investigational gel, multiple daily application on hypertrophic scar lesions for scheduled treatment period.
ETD-001 gelDrug
Topical investigational gel (higher concentration), multiple daily application on hypertrophic scar lesions for scheduled treatment period.
PlaceboOther
Matched topical placebo gel, identical appearance and administration regimen, applied on hypertrophic scar lesions
| Study group | Role | What they receive |
|---|---|---|
| ETD-001 gel dose1 | Experimental | ETD-001 gel Receives: Drug: ETD-001 gel |
| ETD-001 gel dose2 | Experimental | Not described Receives: Drug: ETD-001 gel |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Preliminary Efficacy of ETD-001 Gel in the Treatment of Hypertrophic Scars ：Change from Baseline in Modified Vancouver Scar Scale (mVSS) Score
Measured: 4~12weeks
Secondary outcomes (1)
To Evaluate the safety of ETD-001 Gel in the Treatment of Hypertrophic Scars by CTCAE6.0
Measured: 4~12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start28 Feb 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Etern Therapeutics Wuxi Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891416
- Sponsor's protocol ID
- ETD-001-201
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. Study aggregate results may be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Preliminary Efficacy and Safety of ETD-001 Gel for the Treatment of Hypertrophic Scars
- ClinicalTrials.gov ID
- NCT07891416
- Acronym / sponsor ID
- ETD-001-201
- Conditions
- Hypertrophic Scars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Etern Therapeutics Wuxi LimitedUniversity, hospital or other
- Study start
- 28 Feb 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Oct 2026 (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.
A randomized, double-blind, placebo-controlled multiple dosing study to evaluate the preliminary efficacy and safety of ETD-001 gel for hypertrophic scars. Subjects will be assigned to 3 groups: ETD-001 Dose Group 1, ETD-001 Dose Group 2, and placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ETD-001 gel dose1 | Experimental | Drug: ETD-001 gelETD-001 gel |
| ETD-001 gel dose2 | Experimental | Drug: ETD-001 gel |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Participants with hypertrophic scars aged ≥18 years and <65 years at randomization, with no restriction on sex.
- 2. Subjects experienced burn, surgery, trauma or other events within 6 months prior to screening; the wound has healed and scar formation (linear or extensively growing hypertrophic scar) confirmed by investigator assessment.
- 3. The target treatment scar selected upon investigator judgment meets the morphological characteristics of hypertrophic scar: the scar rises above normal skin tissue, confined within the lesion area, and the subject reports no obvious spontaneous scar regression recently.
- 4. The modified Vancouver Scar Scale (mVSS) score of the target scar is between 7 and 15, inclusive.
Key exclusion criteria (8 listed)
- 1. The target scar is located on the head and face, both hands, genitals, or areas with severely limited joint movement.
- 2. Subjects who received systemic or intralesional corticosteroids (triamcinolone acetonide, betamethasone, etc.), immunosuppressants, chemotherapeutic agents (5-fluorouracil, bleomycin, mitomycin C, etc.), biological products (botulinum toxin, hyaluronidase, interferon, etc.) for scar treatment within 2 months prior to dosing.
- 3. Subjects who received scar treatments including laser, radiotherapy, cryotherapy, compression therapy within 2 months prior to dosing.
- 4. Subjects with local infection on the hypertrophic target scar at screening, or with systemic infection.
- 5. Subjects diagnosed with keloid, atrophic scar or scar carcinoma. 6. Subjects with previous or current clinically significant diseases including but not limited to diseases of digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, immune, neuropsychiatric, hematological systems, or history of malignant tumors, who are judged by the investigator to be unsuitable for enrollment.
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 |
|---|---|---|
| ETD-001 gelTopical investigational gel, multiple daily application on hypertrophic scar lesions for scheduled treatment period. | Drug | ETD-001 gel dose1 |
| ETD-001 gelTopical investigational gel (higher concentration), multiple daily application on hypertrophic scar lesions for scheduled treatment period. | Drug | ETD-001 gel dose2 |
| PlaceboMatched topical placebo gel, identical appearance and administration regimen, applied on hypertrophic scar lesions | Other | Placebo |
Primary outcome
To Evaluate the Preliminary Efficacy of ETD-001 Gel in the Treatment of Hypertrophic Scars ：Change from Baseline in Modified Vancouver Scar Scale (mVSS) Score
Time frame: 4~12weeks
1 secondary outcome
To Evaluate the safety of ETD-001 Gel in the Treatment of Hypertrophic Scars by CTCAE6.0
Time frame: 4~12weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. Study aggregate results may be published in peer-reviewed journals.
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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.
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 ETD-001 gel in people with Hypertrophic Scars, run by Etern Therapeutics Wuxi Limited at 1 site in China.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qian guo NA (86-15093195020, qian.guo@eternbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate the Preliminary Efficacy of ETD-001 Gel in the Treatment of Hypertrophic Scars ：Change from Baseline in Modified Vancouver Scar Scale (mVSS) Score (time frame: 4~12weeks). 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 23 Oct 2026.