Pigmented Post Acne ScarsNCT06151041
Microneedling Combined With Either Tranexamic Acid or PRP in Treatment of Pigmented Postacne Scars
An observational study of Pigmented Post Acne Scars, run by Assiut University.
Trial summary
To evaluate the efficacy of Microneedling combined with Tranxemic acid compared with Micronedlling with PRP in treatment of Pigmented Post Acne Scars. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Pigmented Post Acne Scars
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Nov 2024
- Phase
- Observational
- 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 35 years
- All sexes
- Adult
Study population: This split face comparative study included 40 patients , their ages ranging from 18-35 years old , Presented to our dermatological department and outpatient basis with the main complaint of post acne scars . The morphology of each scar must be assessed , and treatment designed according to the all types of scars , overall appearance and expectations of the patient. The patient must be adequately counseled that the goal of treatment is improvement rather than perfection , as deep scars cannot be entirely eliminated
Who may be able to join
- - 40 Male or Female healthy patient with Pigmented facial acne scars.
- - Age of patient 18 -35 years old .
- - Co-operative patients .
- - No history of allergy to traneximc acid .
- - No history of bleeding disorder
Who cannot join
- Presence of active Acne Lesions .
- Patients having Keloid scaring and Keloid tendency .
- History of bleeding disorder.
- History of anticoagulant therapy.
- Active Skin infection like Warts , Hereps , Bacterial infection .
- Pregenancy and Lactation .
Show all 9Show fewer
- Patients below 18 years .
- History of laser treatment or any other acne therapy within one month .
- Use of any acne medication in oral and topical forms , including retiniods , antibiotics
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microneedling Combined With Either Tranexamic Acid or PRP in Treatment of Pigmented Postacne Scars : A Split Face Comparative Study
To evaluate the efficacy of Microneedling combined with Tranxemic acid compared with Micronedlling with PRP in treatment of Pigmented Post Acne Scars.
Read the detailed description
Acne is a multifactorial chronic inflammatory disease of pilosebaceous unit, clinically characterised by the presence of comedones, inflammatory papules, pustules and sometimes nodules and cysts. It commonly occurs during adolescence and cause great psychological stress. Unfortunately, acne scarring is common and occurs easily in the course of the disease. It is one of the most common causes of facial scarring and treating acne scar is one of the most challenging cosmetic procedures . Patient with acne vulgaries is not only experience the primary inflammatory and non-inflammatory lesions, but also have secondary lesions such as scars, excoriations, post-inflammatory erythema, and dyspigmentation. Acne scars are pleomorphic and difficult to count or even photograph, and consensus concerning acne scar nomenclature and classification remains a matter of debate .
The pathophysiology driving acne scar development is attributed to an altered wound healing response initiated by cutaneous inflammation, leading to an imbalance in matrix degradation and collagen biosynthesis .
The ultimate severity is correlated with acne grade and delay in treatment of active disease . The end result is either an excess of collagen that manifests as hypertrophic/keloid scars or, more commonly, decreased collagen deposition that manifests as atrophic acne scars in 80 to 90 percent of cases.
Tranexamic acid (TXA); a plasmin inhibitor used to prevent fibrinolysis to reduce blood loss , is now gaining popularity as a depigmenting agent as it can block melanin synthesis in melanocytes by inhibiting plasmin-plasminogen system , as well as competitive-inhibition of tyrosinase activity due to its similarity to tyrosine structure .
Microneedling has been used to treat various dermatologic conditions, including scars, rhytides, and dyschromia . The treatment causes small channels of epidermal and dermal injury through the use of needles that puncture the skin . The damaged collagen is removed, and new growth and remodeling subsequently occur . The release of platelet-derived growth factors, fibroblasts, and elastic fiber formation contribute to neovascularization and neocollagenesis ..
Ultimately, this improves the appearance of scars, especially atrophic scars. Since microneedling minimally alters the epidermis, there are limited adverse effects and downtime compared to more invasive .
PRP consists of the patient's own plasma that is enriched with a concentration of platelets that exceeds normal levels. It also contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TFG), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors stimulate tissue remodeling and are associated with enhanced healing through the attraction of macrophages, upregulation of collagen synthesis, and promotion of tissue regeneration .
Microneedling has been known to be an effective treatment option for acne scars; however, the addition of PRP has only recently been investigated. The upregulation of growth factors associated with PRP is believed to augment the effects of microneedling to promote aesthetically superior tissue remodeling. Their synergistic effects offer a unique treatment approach .
- Conditions
- Pigmented Post Acne Scars
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars
To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars in 1 year and this evaluation can be measured by a Questionnaire throught study completion and take photograghes each session .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pigmented Post Acne ScarsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Youssef Mahmoud Moustafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151041
- Sponsor's protocol ID
- post acne scars
- Status last verified
- Nov 2023
- First submitted
- 26 May 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khunger N; IADVL Task Force. Standard guidelines of care for acne surgery. Indian J Dermatol Venereol Leprol. 2008 Jan;74 Suppl:S28-36.
PubMed 18688101Lee WJ, Jung HJ, Lim HJ, Jang YH, Lee SJ, Kim DW. Serial sections of atrophic acne scars help in the interpretation of microscopic findings and the selection of good therapeutic modalities. J Eur Acad Dermatol Venereol. 2013 May;27(5):643-6. doi: 10.1111/j.1468-3083.2011.04330.x. Epub 2011 Nov 5.
PubMed 22054253Layton 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 7955470
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling Combined With Either Tranexamic Acid or PRP in Treatment of Pigmented Postacne Scars : A Split Face Comparative Study
- ClinicalTrials.gov ID
- NCT06151041
- Acronym / sponsor ID
- post acne scars
- Conditions
- Pigmented Post Acne Scars
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 30 Nov 2023 (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.
To evaluate the efficacy of Microneedling combined with Tranxemic acid compared with Micronedlling with PRP in treatment of Pigmented Post Acne Scars.
Detailed description
Acne is a multifactorial chronic inflammatory disease of pilosebaceous unit, clinically characterised by the presence of comedones, inflammatory papules, pustules and sometimes nodules and cysts. It commonly occurs during adolescence and cause great psychological stress. Unfortunately, acne scarring is common and occurs easily in the course of the disease. It is one of the most common causes of facial scarring and treating acne scar is one of the most challenging cosmetic procedures . Patient with acne vulgaries is not only experience the primary inflammatory and non-inflammatory lesions, but also have secondary lesions such as scars, excoriations, post-inflammatory erythema, and dyspigmentation. Acne scars are pleomorphic and difficult to count or even photograph, and consensus concerning acne scar nomenclature and classification remains a matter of debate .
The pathophysiology driving acne scar development is attributed to an altered wound healing response initiated by cutaneous inflammation, leading to an imbalance in matrix degradation and collagen biosynthesis .
The ultimate severity is correlated with acne grade and delay in treatment of active disease . The end result is either an excess of collagen that manifests as hypertrophic/keloid scars or, more commonly, decreased collagen deposition that manifests as atrophic acne scars in 80 to 90 percent of cases.
Tranexamic acid (TXA); a plasmin inhibitor used to prevent fibrinolysis to reduce blood loss , is now gaining popularity as a depigmenting agent as it can block melanin synthesis in melanocytes by inhibiting plasmin-plasminogen system , as well as competitive-inhibition of tyrosinase activity due to its similarity to tyrosine structure .
Microneedling has been used to treat various dermatologic conditions, including scars, rhytides, and dyschromia . The treatment causes small channels of epidermal and dermal injury through the use of needles that puncture the skin . The damaged collagen is removed, and new growth and remodeling subsequently occur . The release of platelet-derived growth factors, fibroblasts, and elastic fiber formation contribute to neovascularization and neocollagenesis ..
Ultimately, this improves the appearance of scars, especially atrophic scars. Since microneedling minimally alters the epidermis, there are limited adverse effects and downtime compared to more invasive .
PRP consists of the patient's own plasma that is enriched with a concentration of platelets that exceeds normal levels. It also contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TFG), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors stimulate tissue remodeling and are associated with enhanced healing through the attraction of macrophages, upregulation of collagen synthesis, and promotion of tissue regeneration .
Microneedling has been known to be an effective treatment option for acne scars; however, the addition of PRP has only recently been investigated. The upregulation of growth factors associated with PRP is believed to augment the effects of microneedling to promote aesthetically superior tissue remodeling. Their synergistic effects offer a unique treatment approach .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- This split face comparative study included 40 patients , their ages ranging from 18-35 years old , Presented to our dermatological department and outpatient basis with the main complaint of post acne scars . The morphology of each scar must be assessed , and treatment designed according to the all types of scars , overall appearance and expectations of the patient. The patient must be adequately counseled that the goal of treatment is improvement rather than perfection , as deep scars cannot be entirely eliminated
Key inclusion criteria (5 listed)
- - 40 Male or Female healthy patient with Pigmented facial acne scars.
- - Age of patient 18 -35 years old .
- - Co-operative patients .
- - No history of allergy to traneximc acid .
- - No history of bleeding disorder
Key exclusion criteria (9 listed)
- Presence of active Acne Lesions .
- Patients having Keloid scaring and Keloid tendency .
- History of bleeding disorder.
- History of anticoagulant therapy.
- Active Skin infection like Warts , Hereps , Bacterial infection .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars
Time frame: 1 year
To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars in 1 year and this evaluation can be measured by a Questionnaire throught study completion and take photograghes each session .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 18688101Khunger N; IADVL Task Force. Standard guidelines of care for acne surgery. Indian J Dermatol Venereol Leprol. 2008 Jan;74 Suppl:S28-36.
- Background: PubMed 22054253Lee WJ, Jung HJ, Lim HJ, Jang YH, Lee SJ, Kim DW. Serial sections of atrophic acne scars help in the interpretation of microscopic findings and the selection of good therapeutic modalities. J Eur Acad Dermatol Venereol. 2013 May;27(5):643-6. doi: 10.1111/j.1468-3083.2011.04330.x. Epub 2011 Nov 5.
- 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.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmented Post Acne Scars, run by Assiut University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Youssef, Doctor (01012148725, reham808@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars (time frame: 1 year). 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 NCT06151041, which also lists 3 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 30 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.