Atrophic Acne ScarNCT06319768
Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined Pentoxifylline With Platelet-Rich Plasma in Patients With Atrophic Acne Scars
A study testing Pentoxifylline, platelet rich plasma and combined pentoxifylline and platelet rich plasma in people with Atrophic Acne Scar, run by Sohag University at 1 site in Egypt.
Trial summary
Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Pentoxifylline, platelet rich plasma and combined pentoxifylline and platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 15 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18 years old.
- Both sexes.
- All types of atrophic acne scars
Who cannot join
- • Pregnant or lactating women.
- Coagulation disorders or anemia.
- Skin infections.
- Patients with hormonal disturbance.
- Chronic disease e.g: diabetes, renal disease….etc.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
Mohammed M Ali, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Official title: Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined
Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . The process of acne scar formation can be broadly divided into two stages: increased tissue formation and loss or damage of tissue, corresponding to keloid or hypertrophic scar and atrophic scar, respectively.
The ultimate severity of acne scars is correlated with acne grade and the delay in treatment of active disease. The atrophic scars include three subtypes: icepick or V-shaped, rolling or M-shaped, and boxcar or U-shaped scars. Among atrophic scars, the ice pick type represents 60%-70%; the boxcar type represents 20%-30%; and the rolling type represents 15%-25% (Salameh and Shumaker, 2022). According to the qualitative scarring grading system, a macular acne scar type also exists, which clinically shows erythematous, hyperpigmented, or hypopigmented flat marks.
autologous blood product containing high concentrations of platelets in a small volume of plasma. PRP has been utilized in the treatment of orthopedic, musculoskeletal, and maxillofacial conditions for many years, it has only recently gained popularity in dermatology. PRP 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. Moreover, platelet-derived growth factor (PDGF) was shown to promote wound healing, angiogenesis, and tissue remodeling.
- Conditions
- Atrophic Acne Scar
- Being tested
- Pentoxifylline, platelet rich plasma, combined pentoxifylline and platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Patients will be treated with intralesional PTX (Trentoximal Ampoule 100 mg/5 ml) in a dose of 1mg per lesion at a distance 1cm between two atrophic lesions with a maximum 20 mg per session (with insulin syringe 30Gx8mm). Lesion blanching is the endpoint of injection
platelet rich plasmaDrug
Patients will be treated with intralesional PRP. PRP will be obtained by the double-spin method, followed by the collection of 10 mL of autologous whole blood into tubes containing trisodium citrate as an anticoagulant. The collected blood will first be centrifuged at 1000 RPM for 10 minutes at room temperature to separate the red blood cells at the bottom of the tube, the buffy coat (containing the white blood cells) in the middle, and the plasma above (soft spin). Then, the upper plasma will be pipetted above the buffy coat to undergo another centrifugation at 1500 RPM for another10 minutes (hard spin) to obtain a platelet pellet in the bottom of the tube (with a platelet count 4-4.5 times higher than that of baseline) and a platelet-poor plasma(PPP) in the upper part. The PPP will be partly removed and partly used to re-suspend the platelets to finally produce 2 mL of PRP
combined pentoxifylline and platelet rich plasmaDrug
Patients will be treated with a combination of both intralesional 1mg of PTX per lesion (with a maximum 20mg per session) then 0.1ml of intralesional PRP at the same lesion after 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| - In group A (PTX group) (n:25): | Active comparator | Patients will be treated with intralesional PTX (Trentoximal Ampoule 100 mg/5 ml) in a dose of 1mg per lesion at a distance 1cm between two atrophic lesions with a maximum 20 mg per session (with insulin syringe 30Gx8mm). Lesion blanching is the endpoint of injection. Receives: Drug: Pentoxifylline |
| - In group B(PRP group) (n:25): | Active comparator | Patients will be treated with intralesional PRP. PRP will be obtained by the double-spin method, followed by the collection of 10 mL of autologous whole blood into tubes containing trisodium citrate as an anticoagulant. The collected blood will first be centrifuged at 1000 RPM for 10 minutes at room temperature to separate the red blood cells at the bottom of the tube, the buffy coat (containing the white blood cells) in the middle, and the plasma above (soft spin). Then, the upper plasma will be pipetted above the buffy coat to undergo another centrifugation at 1500 RPM for another10 minutes (hard spin) to obtain a platelet pellet in the bottom of the tube (with a platelet count 4-4.5 times higher than that of baseline) and a platelet-poor plasma(PPP) in the upper part. The PPP will be partly removed and partly used to re-suspend the platelets to finally produce 2 mL of PRP. Receives: Drug: platelet rich plasma |
| - In group C (combined PTX & PRP) (n:25): | Active comparator | Patients will be treated with a combination of both intralesional 1mg of PTX per lesion (with a maximum 20mg per session) then 0.1ml of intralesional PRP at the same lesion after 5 minutes. Receives: Drug: combined pentoxifylline and platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
goodman and baron qualitative grading system of postacne scarring
- The physician's clinical assessment will be performed for all groups by grading the scars before the treatment at baseline, after each treatment session, and 3 months after the last session. Any changes in scar grading will be documented using the Goodman and Baron qualitative acne scarring grading system, with four grades: Grade 1 states the macular scars. Grades 2, 3, and 4 represent mild, moderate, and sever atrophic acne scars, respectively
- Group B (n: 25): Will receive intralesional injection of PRP.
- Group C (n: 25): Will receive combined intralesional injection of both PTX \& PRP.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Jan 2024
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
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 ScarStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mossad Soliman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319768
- Sponsor's protocol ID
- soh-med-24-01-04ms
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alves R, Grimalt R. Platelet-Rich Plasma and its Use for Cicatricial and Non-Cicatricial Alopecias: A Narrative Review. Dermatol Ther (Heidelb). 2020 Aug;10(4):623-633. doi: 10.1007/s13555-020-00408-5. Epub 2020 Jun 17.
PubMed 32557337Balazic E, Axler E, Konisky H, Khanna U, Kobets K. Pentoxifylline in dermatology. J Cosmet Dermatol. 2023 Feb;22(2):410-417. doi: 10.1111/jocd.15445. Epub 2022 Oct 31.
PubMed 36208009Bhargava S, Kroumpouzos G, Varma K, Kumar U. Combination therapy using subcision, needling, and platelet-rich plasma in the management of grade 4 atrophic acne scars: A pilot study. J Cosmet Dermatol. 2019 Aug;18(4):1092-1097. doi: 10.1111/jocd.12935. Epub 2019 Mar 28.
PubMed 30924301Connolly 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.
PubMed 29344322
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined
- ClinicalTrials.gov ID
- NCT06319768
- Acronym / sponsor ID
- soh-med-24-01-04ms
- Conditions
- Atrophic Acne Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 20 Mar 2024 (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.
Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . The process of acne scar formation can be broadly divided into two stages: increased tissue formation and loss or damage of tissue, corresponding to keloid or hypertrophic scar and atrophic scar, respectively.
The ultimate severity of acne scars is correlated with acne grade and the delay in treatment of active disease. The atrophic scars include three subtypes: icepick or V-shaped, rolling or M-shaped, and boxcar or U-shaped scars. Among atrophic scars, the ice pick type represents 60%-70%; the boxcar type represents 20%-30%; and the rolling type represents 15%-25% (Salameh and Shumaker, 2022). According to the qualitative scarring grading system, a macular acne scar type also exists, which clinically shows erythematous, hyperpigmented, or hypopigmented flat marks.
autologous blood product containing high concentrations of platelets in a small volume of plasma. PRP has been utilized in the treatment of orthopedic, musculoskeletal, and maxillofacial conditions for many years, it has only recently gained popularity in dermatology. PRP 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. Moreover, platelet-derived growth factor (PDGF) was shown to promote wound healing, angiogenesis, and tissue remodeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| - In group A (PTX group) (n:25): | Active comparator | Drug: PentoxifyllinePatients will be treated with intralesional PTX (Trentoximal Ampoule 100 mg/5 ml) in a dose of 1mg per lesion at a distance 1cm between two atrophic lesions with a maximum 20 mg per session (with insulin syringe 30Gx8mm). Lesion blanching is the endpoint of injection. |
| - In group B(PRP group) (n:25): | Active comparator | Drug: platelet rich plasmaPatients will be treated with intralesional PRP. PRP will be obtained by the double-spin method, followed by the collection of 10 mL of autologous whole blood into tubes containing trisodium citrate as an anticoagulant. The collected blood will first be centrifuged at 1000 RPM for 10 minutes at room temperature to separate the red blood cells at the bottom of the tube, the buffy coat (containing the white blood cells) in the middle, and the plasma above (soft spin). Then, the upper plasma will be pipetted above the buffy coat to undergo another centrifugation at 1500 RPM for another10 minutes (hard spin) to obtain a platelet pellet in the bottom of the tube (with a platelet count 4-4.5 times higher than that of baseline) and a platelet-poor plasma(PPP) in the upper part. The PPP will be partly removed and partly used to re-suspend the platelets to finally produce 2 mL of PRP. |
| - In group C (combined PTX & PRP) (n:25): | Active comparator | Drug: combined pentoxifylline and platelet rich plasmaPatients will be treated with a combination of both intralesional 1mg of PTX per lesion (with a maximum 20mg per session) then 0.1ml of intralesional PRP at the same lesion after 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged > 18 years old.
- Both sexes.
- All types of atrophic acne scars
Key exclusion criteria (6 listed)
- • Pregnant or lactating women.
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 |
|---|---|---|
| PentoxifyllinePatients will be treated with intralesional PTX (Trentoximal Ampoule 100 mg/5 ml) in a dose of 1mg per lesion at a distance 1cm between two atrophic lesions with a maximum 20 mg per session (with insulin syringe 30Gx8mm). Lesion blanching is the endpoint of injection | Drug | - In group A (PTX group) (n:25): |
| platelet rich plasmaPatients will be treated with intralesional PRP. PRP will be obtained by the double-spin method, followed by the collection of 10 mL of autologous whole blood into tubes containing trisodium citrate as an anticoagulant. The collected blood will first be centrifuged at 1000 RPM for 10 minutes at room temperature to separate the red blood cells at the bottom of the tube, the buffy coat (containing the white blood cells) in the middle, and the plasma above (soft spin). Then, the upper plasma will be pipetted above the buffy coat to undergo another centrifugation at 1500 RPM for another10 minutes (hard spin) to obtain a platelet pellet in the bottom of the tube (with a platelet count 4-4.5 times higher than that of baseline) and a platelet-poor plasma(PPP) in the upper part. The PPP will be partly removed and partly used to re-suspend the platelets to finally produce 2 mL of PRP | Drug | - In group B(PRP group) (n:25): |
| combined pentoxifylline and platelet rich plasmaPatients will be treated with a combination of both intralesional 1mg of PTX per lesion (with a maximum 20mg per session) then 0.1ml of intralesional PRP at the same lesion after 5 minutes | Drug | - In group C (combined PTX & PRP) (n:25): |
Primary outcome
goodman and baron qualitative grading system of postacne scarring
Time frame: 6 months
* The physician's clinical assessment will be performed for all groups by grading the scars before the treatment at baseline, after each treatment session, and 3 months after the last session. Any changes in scar grading will be documented using the Goodman and Baron qualitative acne scarring grading system, with four grades: Grade 1 states the macular scars. Grades 2, 3, and 4 represent mild, moderate, and sever atrophic acne scars, respectively * Group B (n: 25): Will receive intralesional injection of PRP. * Group C (n: 25): Will receive combined intralesional injection of both PTX \& PRP.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 32557337Alves R, Grimalt R. Platelet-Rich Plasma and its Use for Cicatricial and Non-Cicatricial Alopecias: A Narrative Review. Dermatol Ther (Heidelb). 2020 Aug;10(4):623-633. doi: 10.1007/s13555-020-00408-5. Epub 2020 Jun 17.
- Background: PubMed 36208009Balazic E, Axler E, Konisky H, Khanna U, Kobets K. Pentoxifylline in dermatology. J Cosmet Dermatol. 2023 Feb;22(2):410-417. doi: 10.1111/jocd.15445. Epub 2022 Oct 31.
- Background: PubMed 30924301Bhargava S, Kroumpouzos G, Varma K, Kumar U. Combination therapy using subcision, needling, and platelet-rich plasma in the management of grade 4 atrophic acne scars: A pilot study. J Cosmet Dermatol. 2019 Aug;18(4):1092-1097. doi: 10.1111/jocd.12935. Epub 2019 Mar 28.
- Background: PubMed 29344322Connolly 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.
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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.
Mohammed M Ali, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline, platelet rich plasma and combined pentoxifylline and platelet rich plasma in people with Atrophic Acne Scar, run by Sohag University 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 3 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARIAM M SOLIMAN, resident (01151180969, mariam-mosaad-post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
goodman and baron qualitative grading system of postacne scarring (time frame: 6 months). 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 NCT06319768, 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 20 Mar 2024.