- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07352215
PRP Plus Fractional CO₂ Laser for Acne Scars (PRPLT)
Evaluating the Effectiveness of Platelet-Rich Plasma as an Adjunct to Fractional Carbon Dioxide Laser Therapy in Improving Facial Acne Scar Appearance: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate whether adding platelet-rich plasma (PRP) to fractional CO₂ laser resurfacing improves the treatment of moderate-to-severe acne scars compared with laser alone. Seventy adults aged 18-40 years will be recruited from the Dermatology Department of Gujranwala Medical College Teaching Hospital. Participants will be randomly assigned to receive either fractional CO₂ laser combined with topical PRP or fractional CO₂ laser alone, with three treatment sessions delivered four weeks apart.
The primary outcome is the change in acne scar severity measured using the Goodman and Baron Quantitative Acne Scar Scale. Secondary outcomes include redness, edema, pain scores, and patient satisfaction assessed using Likert and numeric rating scales. The study is single-blinded, with patients unaware of treatment allocation. PRP will be prepared using a standardized double-spin centrifugation process. Data will be analyzed using appropriate statistical tests with a significance level of p < 0.05. The study aims to determine whether PRP enhances laser efficacy, reduces side effects, and improves patient-reported outcomes.
Study Overview
Status
Intervention / Treatment
Detailed Description
Acne scarring is a frequent and distressing outcome of acne vulgaris. Fractional carbon dioxide (CO₂) laser therapy is widely used for acne scar management because it creates controlled microthermal zones that stimulate collagen remodeling and improve skin texture. However, laser treatment alone may lead to side effects such as erythema, edema, discomfort, and variable degrees of clinical improvement.
Platelet-rich plasma (PRP) is an autologous biological product containing high concentrations of platelets, growth factors, and cytokines known to promote wound healing, enhance collagen production, and modulate inflammation. The combination of PRP with fractional CO₂ laser treatment is believed to enhance clinical results, improve healing time, and reduce post-procedural complications. This study is designed to evaluate whether adding PRP to fractional CO₂ laser improves outcomes for patients with moderate-to-severe acne scars.
This randomized controlled trial will recruit 70 patients aged 18-40 years with moderate-to-severe facial acne scars. Participants will be randomly allocated into two groups. Group A will receive fractional CO₂ laser therapy combined with PRP, and Group B will receive fractional CO₂ laser therapy alone. Both groups will undergo three treatment sessions spaced four weeks apart. The study uses single blinding, where patients are unaware of their treatment assignment. To maintain blinding, a placebo-filled syringe will be used in the control group and gently applied without injecting any substance.
PRP will be prepared using a standardized double-spin method. Ten milliliters of venous blood will be collected in anticoagulant tubes, centrifuged at low speed to separate plasma and buffy coat, followed by a second high-speed centrifugation to isolate platelet-rich plasma. Topical anesthesia with lignocaine-prilocaine cream will be applied before each laser session. Treatment areas will be prepared using antiseptic measures, and eye protection will be provided.
Outcome assessment will be performed at baseline and at each visit. The primary outcome is the change in acne scar severity measured using the Goodman and Baron Quantitative Acne Scar Scale. Secondary outcomes include assessments of erythema and edema by the evaluator, as well as patient-reported pain scores and satisfaction ratings. Standardized clinical photographs will support patient self-assessment under consistent lighting and camera settings.
Data will be analyzed using appropriate statistical methods. Continuous variables will be assessed for normality and compared using t-tests or nonparametric equivalents. Categorical and ordinal data will be analyzed using Chi-square or related tests. A significance level of p < 0.05 will be applied. Data will be coded, and the statistician will remain blinded to group allocation.
The purpose of this trial is to determine whether PRP enhances the efficacy, safety profile, and patient satisfaction of fractional CO₂ laser treatments. If successful, this combination approach may offer a more effective therapeutic option for managing moderate-to-severe acne scarring.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: YASAAN SAAQIB, MBBS
- Phone Number: 0923234525277
- Email: saani1992222@gmail.com
Study Contact Backup
- Name: Nabeela Shahzadi
- Phone Number: +92 331 4218784
- Email: nabeela.pk82@gmail.com
Study Locations
-
-
Punjab Province
-
Gujranwala, Punjab Province, Pakistan, 52250
- Recruiting
- Destrict Head Quarter Hospital, Gujranwala
-
Contact:
- Syed Asif Ali, MS Artho
- Phone Number: 119 055-6705800-4
- Email: principal@gmcg.edu.pk
-
Contact:
- Nabeela Shahzadi, FCPS Derma
- Phone Number: +92 331 4218784
- Email: nabeela.pk82@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Adults aged 18 to 40 years
Male and female participants
Fitzpatrick skin types I to V
Presence of moderate-to-severe acne scars
Willing to undergo 3 treatment sessions and follow-up visits
Able to provide informed consent -
Exclusion Criteria:Use of topical anti-acne medications in the past 1 month
History of keloid formation or hypertrophic scarring
Active acne or active skin inflammation at treatment area
Diabetes mellitus
Photosensitive disorders (e.g., lupus, dermatomyositis)
Melasma
Active infections (e.g., Herpes simplex)
Recent laser resurfacing or similar procedures
Outdoor workers with high sun exposure
Vitiligo
Pregnancy or breastfeeding
Bleeding disorders or anticoagulant therapy
Unrealistic expectations or inability to comply with follow-up
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laser + PRP arm
Participants receive fractional CO₂ laser treatment followed by the application of autologous platelet-rich plasma (PRP).
Three sessions are administered at four-week intervals.
PRP is prepared using a double-spin centrifugation method and applied topically immediately after laser treatment.
|
Fractional CO₂ Laser + Platelet-Rich Plasma (PRP) Participants receive fractional CO₂ laser treatment followed by topical application of autologous platelet-rich plasma. Three treatment sessions are performed at four-week intervals. PRP is prepared using a standardized double-spin centrifugation method from 10 mL of the participant's blood. After laser resurfacing, the PRP is applied immediately to the treated area to enhance healing and collagen remodeling. |
|
Experimental: Laser only arm
Participants receive fractional CO₂ laser treatment alone, without PRP.
Three sessions are administered at four-week intervals using the same laser parameters as the intervention group.
To maintain masking, a placebo-filled syringe covered with opaque tape is touched to the skin without delivering PRP.
|
Fractional CO₂ Laser Only Participants receive fractional CO₂ laser treatment alone, with the same laser settings and treatment schedule as the intervention group. Three sessions are performed at four-week intervals. To maintain participant blinding, a placebo-filled syringe covered with opaque tape is applied to the skin without delivering PRP. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Acne Scar Severity (Goodman and Baron Quantitative Acne Scar Scale)
Time Frame: 12weeks
|
Acne scar severity will be assessed using the Goodman and Baron Quantitative Acne Scar Scale, which grades scars based on type, number of lesions, and affected surface area.
Scores will be recorded at baseline and at each follow-up visit to measure improvement over the course of treatment.
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Redness (Erythema) Score
Time Frame: 12weeks
|
Redness will be evaluated by the assessor using a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit to assess post-laser inflammatory response.
|
12weeks
|
|
Edema (Swelling) Score
Time Frame: 12 weeks
|
Edema will be assessed by the evaluator using a 4-point Likert scale ranging from 0 (none) to 3 (severe) to evaluate treatment-related swelling.
|
12 weeks
|
|
Pain Score (11-Point Numeric Rating Scale)
Time Frame: 12 weeks
|
Participants will report pain intensity using an 11-point numeric scale (0 = no pain; 10 = worst possible pain) during and after each treatment session.
|
12 weeks
|
|
Patient Satisfaction Rating
Time Frame: 12 weeks
|
Patient satisfaction with treatment outcome will be measured using a 4-point Likert scale (0 = not satisfied; 1 = neutral; 2 = satisfied; 3 = very satisfied).
Standardized digital photographs will be used to assist patient self-evaluation.
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: YASAAN SAAQIB, Gujranwala Medial College Gujranwala
Publications and helpful links
General Publications
- Rullan PP, Olson R, Lee KC. A Combination Approach to Treating Acne Scars in All Skin Types: Carbolic Chemical Reconstruction of Skin Scars, Blunt Bi-level Cannula Subcision, and Microneedling-A Case Series. J Clin Aesthet Dermatol. 2020 May;13(5):19-23. Epub 2020 May 1.
- Connolly D, Vu HL, Mariwalla K, Saedi N. Acne Scarring-Pathogenesis, Evaluation, and Treatment Options. J Clin Aesthet Dermatol. 2017 Sep;10(9):12-23. Epub 2017 Sep 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- No. IRB.22/ GMC
- CPSP/REU/DER-2023-093-19340 (Other Identifier: CPSP, Pakistan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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