Acne VulgarisNCT03933033
Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars
A study testing Fractional Erbium Yağ Laser and Platelet Rich Plasma in people with Acne Vulgaris and Scars, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of treatment in comparison with combined treatment in atrophic post acne scars. Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Acne Vulgaris, Scars
- What is being tested?
- Fractional Erbium Yağ Laser and Platelet Rich Plasma
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with atrophic post acne scars classified on the basis of Goodman and Baron's Qualitative classification, no active acne lesions and patients with atrophic scars only
Who cannot join
- patients with positive history of keloidal tendency, positive history of bleeding tendency, platelet disorder, patients with any acute infection on face like, herpes, folliculitis, patients with HIV, HBsAg, patients with a history of autoimmune diseases or patients on immunosuppressive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of treatment in comparison with combined treatment in atrophic post acne scars.
- Conditions
- Acne Vulgaris, Scars
- Being tested
- Fractional Erbium Yağ Laser, Platelet Rich Plasma
- Keywords
- Acne scars, Erbium-YAG laser, platelet-rich plasma
- Medical subject headings
- Acne Vulgaris, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Erbium Yağ LaserDevice
Multiple sessions of Fractional Erbium Yağ Laser
Platelet Rich PlasmaProcedure or surgery
Multiple injections of Platelet Rich Plasma
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | treated with platelet rich plasma Receives: Procedure: Platelet Rich Plasma |
| Group B | Active comparator | treated with Erbium Yag Laser Receives: Device: Fractional Erbium Yağ Laser |
| Group C | Active comparator | treated with both line of treatments Receives: Device: Fractional Erbium Yağ Laser; Procedure: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron
Grade of acne scares improvement after treatment
Measured: 6 months
Change in clinical appearance of acne scare accordinga four-point scale for assessment of clinical improvement of skin smoothness
improvement of acne scares as evaluated by sequential photos
Measured: 6 month
Change in patient satisfaction usinga four-point scale; Grade 4 highly satisfied, Grade 3 satisfied, Grade 2 neutral and Grade 1 dissatisfied
increase in patient satisfaction after treatment
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jun 2017
- Primary completion31 Aug 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South Valley University
- Responsible party
- Principal investigator, Moustafa A. El Taieb, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933033
- Sponsor's protocol ID
- Erbium Yag
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Taieb MA, Ibrahim HM, Hegazy EM, Ibrahim AK, Gamal AM, Nada EA. Fractional Erbium-YAG Laser and Platelet-Rich Plasma as Single or Combined Treatment for Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Ther (Heidelb). 2019 Dec;9(4):707-717. doi: 10.1007/s13555-019-00318-1. Epub 2019 Aug 16.
PubMed 31420849
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03933033
- Acronym / sponsor ID
- Erbium Yag
- Conditions
- Acne Vulgaris, Scars
- Keywords
- Acne scars, Erbium-YAG laser, platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Collaborators
- South Valley University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 1 May 2019 (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.
This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of treatment in comparison with combined treatment in atrophic post acne scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Platelet Rich Plasmatreated with platelet rich plasma |
| Group B | Active comparator | Device: Fractional Erbium Yağ Lasertreated with Erbium Yag Laser |
| Group C | Active comparator | Device: Fractional Erbium Yağ Laser, Procedure: Platelet Rich Plasmatreated with both line of treatments |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with atrophic post acne scars classified on the basis of Goodman and Baron's Qualitative classification, no active acne lesions and patients with atrophic scars only
Key exclusion criteria (1 listed)
- patients with positive history of keloidal tendency, positive history of bleeding tendency, platelet disorder, patients with any acute infection on face like, herpes, folliculitis, patients with HIV, HBsAg, patients with a history of autoimmune diseases or patients on immunosuppressive drugs.
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 |
|---|---|---|
| Fractional Erbium Yağ LaserMultiple sessions of Fractional Erbium Yağ Laser | Device | Group B, Group C |
| Platelet Rich PlasmaMultiple injections of Platelet Rich Plasma | Procedure or surgery | Group A, Group C |
Primary outcome
Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron
Time frame: 6 months
Grade of acne scares improvement after treatment
Change in clinical appearance of acne scare accordinga four-point scale for assessment of clinical improvement of skin smoothness
Time frame: 6 month
improvement of acne scares as evaluated by sequential photos
Change in patient satisfaction usinga four-point scale; Grade 4 highly satisfied, Grade 3 satisfied, Grade 2 neutral and Grade 1 dissatisfied
Time frame: 6 month
increase in patient satisfaction after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 31420849El-Taieb MA, Ibrahim HM, Hegazy EM, Ibrahim AK, Gamal AM, Nada EA. Fractional Erbium-YAG Laser and Platelet-Rich Plasma as Single or Combined Treatment for Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Ther (Heidelb). 2019 Dec;9(4):707-717. doi: 10.1007/s13555-019-00318-1. Epub 2019 Aug 16.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Erbium Yağ Laser and Platelet Rich Plasma in people with Acne Vulgaris and Scars, run by Aswan University Hospital at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2019. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933033, which also lists 1 linked publication.
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 1 May 2019.