Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars

NCT07891416 | Not Yet Recruiting Phase 2

• 1 other identifier: ETD-001-201
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertrophic Scars

Outcome Measures

Primary Outcomes (1)

• 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

  4~12weeks

Secondary Outcomes (1)

• To Evaluate the safety of ETD-001 Gel in the Treatment of Hypertrophic Scars by CTCAE6.0

  4~12weeks

Study Arms (3)

ETD-001 gel dose1

EXPERIMENTAL

ETD-001 gel

Drug: ETD-001 gel

ETD-001 gel dose2

EXPERIMENTAL

Drug: ETD-001 gel

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

ETD-001 gel DRUG

Topical investigational gel, multiple daily application on hypertrophic scar lesions for scheduled treatment period.

ETD-001 gel dose1

Placebo OTHER

Matched topical placebo gel, identical appearance and administration regimen, applied on hypertrophic scar lesions

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participants with hypertrophic scars aged ≥18 years and \<65 years at randomization, with no restriction on sex.
• \. 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.
• \. 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.
• \. The modified Vancouver Scar Scale (mVSS) score of the target scar is between 7 and 15, inclusive.

You may not qualify if:

• \. The target scar is located on the head and face, both hands, genitals, or areas with severely limited joint movement.
• \. 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.
• \. Subjects who received scar treatments including laser, radiotherapy, cryotherapy, compression therapy within 2 months prior to dosing.
• \. Subjects with local infection on the hypertrophic target scar at screening, or with systemic infection.
• \. 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%.

Sponsors & Collaborators

• Etern Therapeutics Wuxi Limited: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

qian guo NA

CONTACT

86-15093195020; qian.guo@eternbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): February 28, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)