NCT07752186

Brief Summary

This randomized controlled trial compared two combined treatment approaches for atrophic acne scars. A total of 100 patients aged 15-45 years were enrolled from the Department of Dermatology, Lahore General Hospital, Lahore, and were randomly assigned to one of two treatment groups. All participants underwent subcision, a minor procedure in which fibrous bands beneath depressed acne scars were released to elevate the scarred skin. Participants in one group received platelet-rich plasma bio-filler injections after subcision. The bio-filler was prepared from each participant's own blood and was injected beneath the acne scars to provide volume and promote collagen formation. Participants in the other group received fractional carbon dioxide laser treatment after subcision. The laser created controlled microscopic skin injuries intended to stimulate collagen production and improve skin texture. Three treatment sessions were administered at 4-week intervals. Treatment outcomes were assessed using the Patient and Observer Scar Assessment Scale at baseline and during follow-up. Treatment-related adverse effects, including pain, erythema, bruising, and changes in skin pigmentation, were also recorded. Treatment efficacy was defined as a reduction of more than 50% in acne scar severity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 3, 2026

Last Update Submit

August 3, 2026

Conditions

Keywords

Acne scarringAtrophic acne scarsRolling acne scarsPlatelet-poor plasma gelPlasma bio-filler

Outcome Measures

Primary Outcomes (2)

  • Change in Patient and Observer Scar Assessment Scale Score

    Atrophic acne scar severity was assessed using the Patient and Observer Scar Assessment Scale. The scale was completed at baseline and at each follow-up assessment. The change in score from baseline was calculated for each participant and compared between the two treatment groups. A greater reduction from the baseline score represented greater improvement in acne scar severity.

    Baseline and 4, 8, and 12 weeks after initiation of treatment.

  • Proportion of Participants Achieving Treatment Efficacy

    Treatment efficacy was defined as a reduction of more than 50% in atrophic acne scar severity compared with baseline. The reduction was determined using the Patient and Observer Scar Assessment Scale. The number and percentage of participants achieving treatment efficacy were calculated for each treatment group.

    12 weeks after initiation of treatment.

Secondary Outcomes (2)

  • Incidence of Treatment-Related Pain

    At 4, 8, and 12 weeks after initiation of treatment.

  • Incidence of Treatment-Related Pigmentary Changes

    At 4, 8, and 12 weeks after initiation of treatment.

Study Arms (2)

Platelet-Rich Plasma Bio-Filler With Subcision

EXPERIMENTAL

Participants received subcision using an 18-gauge cannula with forward-backward and fanning movements. After subcision, 0.1 mL of autologous plasma bio-filler was injected intradermally beneath each marked atrophic acne scar. Three treatment sessions were administered at 4-week intervals.

Biological: Platelet-Rich Plasma Bio-Filler With Subcision

Fractional Carbon Dioxide Laser With Subcision

ACTIVE COMPARATOR

Participants received subcision using an 18-gauge cannula with forward-backward and fanning movements. Subcision was followed by a single pass of fractional carbon dioxide laser treatment. Three treatment sessions were administered at 4-week intervals.

Device: Fractional Carbon Dioxide Laser With Subcision

Interventions

Autologous plasma bio-filler was prepared from 20 mL of venous blood. The blood was centrifuged at 1,500 revolutions per minute for 10 minutes, followed by a second centrifugation at 3,000 revolutions per minute for 10 minutes. Approximately 4-5 mL of the upper plasma layer was collected, heated at 80-100°C for 5 minutes, and subsequently cooled at 0-6°C for 5 minutes to produce a viscous bio-filler. Following subcision, 0.1 mL of the bio-filler was injected beneath each marked scar. Three treatment sessions were provided at 4-week intervals.

Platelet-Rich Plasma Bio-Filler With Subcision

After subcision, the treatment area received a single pass of fractional carbon dioxide laser using a pulse energy of 25 mJ, spot density of 144 spots/cm², pulse interval of 0.5 mm, and pulse duration of 0.1 milliseconds. Three treatment sessions were provided at 4-week intervals.

Fractional Carbon Dioxide Laser With Subcision

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients of age 15-45 years,
  • both genders,
  • presenting with atrophic acne scars

You may not qualify if:

  • Patients with photosensitive dermatosis, keloids, active acne, already taking steroidal, laser or trial treatment in last 6 months, hepatitis B or hepatitis C, hypothyroidism (TSH\>5IU), pregnant or breast feeding, skin infection or inflammatory skin disorders requiring systemic antimicrobials (on medical record).
  • Patients with connective tissue disorders or hypersensitivity to lidocaine, taking antiplatelet therapy, bleeding tendencies (on clinical examination)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

  • Kainat Haq

    Lahore General Hospital, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 7, 2026

Study Start

August 10, 2025

Primary Completion

February 10, 2026

Study Completion

February 10, 2026

Last Updated

August 7, 2026

Record last verified: 2026-08

Locations