NCT07547956

Brief Summary

The aim of this study is to evaluate and compare the efficacy and safety of two different injectable agents combined with subcision for treating rolling acne scars. In this split-face clinical trial, each participant will receive subcision on both sides of the face. One side will then be treated with an injection of Polydeoxyribonucleotide (PDRN), while the other side will receive an injection of non-cross linked Hyaluronic acid (HA). The clinical outcomes and improvement in scar appearance will be assessed and compared between both treatments

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

April 17, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

subcisionPDRNHyakuronic acidatrophic acne scars

Outcome Measures

Primary Outcomes (2)

  • Percent change in atrophic acne scar topography

    Percent change from baseline in acne scar area, volume, and maximum depth as assessed by Antera 3D image analysis

    Baseline, Week 12, and Week 24 (3 months after last injection).

  • Change in Goodman and Baron Quantitative Score.

    Mean change in the Goodman and Baron Quantitative Score for rolling acne scars. The score categorizes severity as: Mild (1 to 6), Moderate (7 to 15), and Severe (16 or above)

    Baseline, Week 12, and Week 24 (3 months after last injection).

Secondary Outcomes (9)

  • Patient and Observer Scar Assessment Scale (POSAS) - Observer Scale

    Baseline, Week 12, and Week 24 (3 months after last injection).

  • Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale

    Baseline, Week 12, and Week 24 (3 months after last injection)

  • Proportion of patients with clinically significant POSAS improvement

    Week 12 and Week 24

  • Proportion of patients with \ge30% improvement in Goodman and Baron score

    Week 12 and Week 24.

  • Change in total atrophic acne scar counts

    Baseline, Week 12, and Week 24.

  • +4 more secondary outcomes

Study Arms (1)

split-face treatment arm

EXPERIMENTAL

Each participant will receive two different treatments: one side of the face will be treated with subcision followed by injection of polydeoxyribonucleotide, while the contralateral side will be treated wit subcision followed by injection of non-cross linked hyaluronic acid

Procedure: subcision with PDRN vs HA injection

Interventions

Each participant will receive two different treatments on each side of the face. One side will be treated with subcision followed by PDRN injection, while the other side will be treated with subcision followed by non-cross linked Hyaluronic Acid injection. Clinical assessment and 3D image analysis will be used for evaluation.

split-face treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe mainly rolling acne scars per validated scale (Goodman \& Baron Grade 3-4)
  • Scars must be bilaterally distributed, allowing for split-face comparison
  • Stable acne (no active nodulocystic lesions, pustules, or recent outbreaks for ≥6 months)
  • No scar treatments (e.g., fillers, laser, microneedling) within the past 12 months
  • All skin types.
  • Both genders above 18 years old

You may not qualify if:

  • Systemic retinoid treatment within the last 6 months
  • Active inflammatory acne
  • Lidocaine sensitivity
  • Pregnancy and lactation
  • Severe systemic illness or malignancy
  • Use of anticoagulant or antiplatelet medications (unless cleared) Use of oral isotretinoin within the past 6 month
  • Herpes libialis, bacterial infection, other infections such as HBV, HCV or HIV
  • Tendency to keloid formation
  • Allergy to fish and salmon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University, Dermatology Department

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Candidate in Dermatology

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

October 20, 2025

Primary Completion

June 20, 2026

Study Completion

July 20, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations