Atrophic Acne ScarsNCT02798016
Treatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling
A study testing Platelet-Rich Plasma and Micro-needling in people with Atrophic Acne Scars, run by Damascus University at 1 site in Syria.
Trial summary
Investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. A split-face design is going to used in this randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrophic Acne Scars
- What is being tested?
- Platelet-Rich Plasma and Micro-needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSyria
- Study dates
- Oct 2015to 20 Oct 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atrophic acne scars on both sides of the face
Who cannot join
- patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer
- systemic retinoids intake in the previous 6 months,
- diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy
- patients on anticoagulant therapy or aspirin or have a coagulation issue,
- patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
- any previous procedures for acne scar within the last 6 months
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Dermatology and Venereology
Damascus, Syrian Arab Republic, DM20AM18
About this study
Official title: Treatment of Atrophic Acne Scars With Platelet-Rich Plasma Alone or in Combination With Skin Needling: A Randomized Controlled Trial
Investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. A split-face design is going to used in this randomized controlled trial. In the control side of the face, micro-needling to the skin will occur using a specific tool (Dermapen).
Read the detailed description
Atrophic acne scar is a common problem with a challenging treatment. Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition.
Skin needling is a technique that uses a sterile micro needles to puncture the skin and release growth factors. The combination of skin needling and PRP could enhance the efficacy of both modalities.
- Conditions
- Atrophic Acne Scars
- Being tested
- Platelet-Rich Plasma, Micro-needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich PlasmaProcedure or surgery
This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars
Micro-needlingProcedure or surgery
Micro-needling will be applied on the acne scars in one side of the face.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma alone | Experimental | The scars will be injected with Platelet-Rich Plasma alone. Receives: Procedure: Platelet-Rich Plasma |
| Platelet-Rich Plasma with micro-needling | Active comparator | The scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma Receives: Procedure: Platelet-Rich Plasma; Procedure: Micro-needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scar Appearance
Measured: Scar Appearance will be assessed at: T1; one day (wihtin 24 hours) before the application of the intervention(s); and T2: after three months of applying the intervention(s).
Secondary outcomes (1)
Patients' Satisfaction
The assessment will be based on a questionnaire
Measured: This is going to be assessed six months following the application of the intervention and the active comparator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startOct 2015
- Primary completion23 Jun 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiez Al-Deghlaoui, MD MSc PhD, Study director, Associate Professor of Dermatology and Veneology, Medical School, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798016
- Sponsor's protocol ID
- UDMS-Dermat-01-2016
- Status last verified
- Dec 2017
- First submitted
- 13 May 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.
PubMed 7955470Cunliffe WJ, Gould DJ. Prevalence of facial acne vulgaris in late adolescence and in adults. Br Med J. 1979 Apr 28;1(6171):1109-10. doi: 10.1136/bmj.1.6171.1109.
PubMed 156054Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
PubMed 10495379Sunitha Raja V, Munirathnam Naidu E. Platelet-rich fibrin: evolution of a second-generation platelet concentrate. Indian J Dent Res. 2008 Jan-Mar;19(1):42-6. doi: 10.4103/0970-9290.38931.
PubMed 18245923
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Atrophic Acne Scars With Platelet-Rich Plasma Alone or in Combination With Skin Needling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02798016
- Acronym / sponsor ID
- UDMS-Dermat-01-2016
- Conditions
- Atrophic Acne Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- 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.
Investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. A split-face design is going to used in this randomized controlled trial. In the control side of the face, micro-needling to the skin will occur using a specific tool (Dermapen).
Detailed description
Atrophic acne scar is a common problem with a challenging treatment. Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition.
Skin needling is a technique that uses a sterile micro needles to puncture the skin and release growth factors. The combination of skin needling and PRP could enhance the efficacy of both modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma alone | Experimental | Procedure: Platelet-Rich PlasmaThe scars will be injected with Platelet-Rich Plasma alone. |
| Platelet-Rich Plasma with micro-needling | Active comparator | Procedure: Platelet-Rich Plasma, Procedure: Micro-needlingThe scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Atrophic acne scars on both sides of the face
Key exclusion criteria (6 listed)
- patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer
- systemic retinoids intake in the previous 6 months,
- diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy
- patients on anticoagulant therapy or aspirin or have a coagulation issue,
- patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
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 |
|---|---|---|
| Platelet-Rich PlasmaThis Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars | Procedure or surgery | Platelet-Rich Plasma alone, Platelet-Rich Plasma with micro-needling |
| Micro-needlingMicro-needling will be applied on the acne scars in one side of the face. | Procedure or surgery | Platelet-Rich Plasma with micro-needling |
Primary outcome
Change in Scar Appearance
Time frame: Scar Appearance will be assessed at: T1; one day (wihtin 24 hours) before the application of the intervention(s); and T2: after three months of applying the intervention(s).
1 secondary outcome
Patients' Satisfaction
Time frame: This is going to be assessed six months following the application of the intervention and the active comparator
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 3 Jan 2018.
- Background: PubMed 7955470Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.
- Background: PubMed 156054Cunliffe WJ, Gould DJ. Prevalence of facial acne vulgaris in late adolescence and in adults. Br Med J. 1979 Apr 28;1(6171):1109-10. doi: 10.1136/bmj.1.6171.1109.
- Background: PubMed 10495379Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
- Background: PubMed 18245923Sunitha Raja V, Munirathnam Naidu E. Platelet-rich fibrin: evolution of a second-generation platelet concentrate. Indian J Dent Res. 2008 Jan-Mar;19(1):42-6. doi: 10.4103/0970-9290.38931.
- Individual participant dataSharing planned: Undecided
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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.
Faiez Al-Deghlaoui, MD MSc PhD study director
Associate Professor of Dermatology and Veneology, Medical School, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma and Micro-needling in people with Atrophic Acne Scars, run by Damascus University at 1 site in Syria.
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 6 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 3 Jan 2018. 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 Syria. 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 Scar Appearance (time frame: Scar Appearance will be assessed at: T1; one day (wihtin 24 hours) before the application of the intervention(s); and T2: after three months of applying the intervention(s).). 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 NCT02798016, which also lists 4 linked publications.
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 3 Jan 2018.