Acne VulgarisNCT06590909
Fractional CO2 Laser Delivery of Topical Insulin Versus Platelet Rich Plasma in Treatment of Atrophic Post Acne Scars
A study testing Fractional CO2 laser assisted PDT in people with Acne Vulgaris, run by Assiut University.
Trial summary
compare the efficacy and safety of treating atrophic post acne scars with topical insulin versus Platelet rich Plasma PRP combined with fractional ablative Co2 laser Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Fractional CO2 laser assisted PDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- patients aged equal or more than 18 years with atrophic post acne scars.
Who cannot join
- pregnancy and lactation. Hypertrophic scars. patients suffering from aggressive inflammatory acne. kidney or liver disease. active infection at site of lesion. patients use medications that reduce tissue healing during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fractional CO2 Laser for Delivery of Topical Insulin Versus Platelet Rich Plasma in Treatment of Atrophic Post Acne Scars: a Split Face Comparative Study
compare the efficacy and safety of treating atrophic post acne scars with topical insulin versus Platelet rich Plasma PRP combined with fractional ablative Co2 laser
Read the detailed description
Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo".
Because of its long duration and exposure to affected areas, acne is associated with a major deterioration in a patient's quality of life and well-being .
Up to 95% of acne sufferers have some degree of acne scarring, with 30% reporting severe acne scarring. Scarring from acne is common when medical care is delayed or is not sufficient, although it can also occur even when treatment is adequate .
About 90% of acne scars are related with collagen loss (atrophic scars), whereas the remaining 10- 20% show collagen gain (keloidal or hypertrophic scars). Resulting from the contraction of fibrous tissue, atrophic scars appear as depressions. Atrophic acne scars can be classified into three distinct types: boxcar, icepick, and rolling.
- Conditions
- Acne Vulgaris
- Being tested
- Fractional CO2 laser assisted PDT
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laser assisted PDTCombination product
Also called topical platelet rich plasma
Comparative split face study: participants will be treated with fractional co2 laser on the whole face then applying topical insulin on the right side of the face and topical platelet rich plasma on the left side of the face.
| Study group | Role | What they receive |
|---|---|---|
| A prospective comparative split face study | Active comparator | Not described Receives: Combination Product: Fractional CO2 laser assisted PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of treating atrophic post acne scars with topical insulin versus PRP combined with fractional ablative Co2 laser.
Scar assessment will be made using the Goodman and Baron Qualitative and Quantitative scarring system at baseline and at each visit to evaluate the clinical improvement.
Measured: 5 months from the beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startNov 2024 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (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 Acne VulgarisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Mohamed Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590909
- Sponsor's protocol ID
- treatment of post acne scars
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan HM, Zhao HJ, Guo DY, Zhu PQ, Zhang CL, Jiang W. Gut microbiota alterations in moderate to severe acne vulgaris patients. J Dermatol. 2018 Oct;45(10):1166-1171. doi: 10.1111/1346-8138.14586. Epub 2018 Aug 13.
PubMed 30101990Szepietowska M, Dabrowska A, Nowak B, Skinderowicz K, Wilczynski B, Krajewski PK, Jankowska-Konsur A. Facial acne causes stigmatization among adolescents: A cross-sectional study. J Cosmet Dermatol. 2022 Dec;21(12):6815-6821. doi: 10.1111/jocd.15268. Epub 2022 Oct 14.
PubMed 35869826Bhargava S, Cunha PR, Lee J, Kroumpouzos G. Acne Scarring Management: Systematic Review and Evaluation of the Evidence. Am J Clin Dermatol. 2018 Aug;19(4):459-477. doi: 10.1007/s40257-018-0358-5.
PubMed 29744784
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Laser for Delivery of Topical Insulin Versus Platelet Rich Plasma in Treatment of Atrophic Post Acne Scars: a Split Face Comparative Study
- ClinicalTrials.gov ID
- NCT06590909
- Acronym / sponsor ID
- treatment of post acne scars
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Sep 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.
compare the efficacy and safety of treating atrophic post acne scars with topical insulin versus Platelet rich Plasma PRP combined with fractional ablative Co2 laser
Detailed description
Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo".
Because of its long duration and exposure to affected areas, acne is associated with a major deterioration in a patient's quality of life and well-being .
Up to 95% of acne sufferers have some degree of acne scarring, with 30% reporting severe acne scarring. Scarring from acne is common when medical care is delayed or is not sufficient, although it can also occur even when treatment is adequate .
About 90% of acne scars are related with collagen loss (atrophic scars), whereas the remaining 10- 20% show collagen gain (keloidal or hypertrophic scars). Resulting from the contraction of fibrous tissue, atrophic scars appear as depressions. Atrophic acne scars can be classified into three distinct types: boxcar, icepick, and rolling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A prospective comparative split face study | Active comparator | Combination Product: Fractional CO2 laser assisted PDT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged equal or more than 18 years with atrophic post acne scars.
Key exclusion criteria (1 listed)
- pregnancy and lactation. Hypertrophic scars. patients suffering from aggressive inflammatory acne. kidney or liver disease. active infection at site of lesion. patients use medications that reduce tissue healing during the study.
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 CO2 laser assisted PDTAlso: topical platelet rich plasmaComparative split face study: participants will be treated with fractional co2 laser on the whole face then applying topical insulin on the right side of the face and topical platelet rich plasma on the left side of the face. | Combination product | A prospective comparative split face study |
Primary outcome
Efficacy and safety of treating atrophic post acne scars with topical insulin versus PRP combined with fractional ablative Co2 laser.
Time frame: 5 months from the beginning of the treatment
Scar assessment will be made using the Goodman and Baron Qualitative and Quantitative scarring system at baseline and at each visit to evaluate the clinical improvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 30101990Yan HM, Zhao HJ, Guo DY, Zhu PQ, Zhang CL, Jiang W. Gut microbiota alterations in moderate to severe acne vulgaris patients. J Dermatol. 2018 Oct;45(10):1166-1171. doi: 10.1111/1346-8138.14586. Epub 2018 Aug 13.
- Background: PubMed 35869826Szepietowska M, Dabrowska A, Nowak B, Skinderowicz K, Wilczynski B, Krajewski PK, Jankowska-Konsur A. Facial acne causes stigmatization among adolescents: A cross-sectional study. J Cosmet Dermatol. 2022 Dec;21(12):6815-6821. doi: 10.1111/jocd.15268. Epub 2022 Oct 14.
- Background: PubMed 29744784Bhargava S, Cunha PR, Lee J, Kroumpouzos G. Acne Scarring Management: Systematic Review and Evaluation of the Evidence. Am J Clin Dermatol. 2018 Aug;19(4):459-477. doi: 10.1007/s40257-018-0358-5.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO2 laser assisted PDT in people with Acne Vulgaris, 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 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hager Gamal, mbBch ((+20)1007436862, hagermohamed21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety of treating atrophic post acne scars with topical insulin versus PRP combined with fractional ablative Co2 laser. (time frame: 5 months from the beginning of the treatment). 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 NCT06590909, 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 19 Sep 2024.