A Phase 2 interventional study of micro-needling with topical human actrapid insulin and Micro-needling with topical Platelet rich plasma in Post-acne Atrophic Scars, sponsored by Sheikh Zayed Medical College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 13 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Sheikh Zayed Medical College · Phase 2, Interventional, and Treatment
Post acne scars are formed as a result of very inflamed and nodulocystic acne. Most common type of acne scars are atrophic scars and they are further classified on the basis of depth and size of destruction into ice pick, boxcar and rolling scars. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars as to find out the relatively more effective and safer treatment.
Acne vulgaris is a disease involving inflammation or blockage of pilosebaceous units. Post acne scars are formed as a result of very inflamed and nodulocystic acne. There are many procedures to treat post-acne scar including lasers, platelet rich plasma, fillers, chemical peeling, pulsed dye lasers, fractional CO2 lasers, subcision and punch techniques, but almost lead to additional scaring and pigmentation.The major purpose of our study is comparison of outcome of micro-needling and platelet rich plasma as opposed to combining it with topical in atrophic scars due to acne, as topical insulin is natural component of body, cheap, easy to use, minimally invasive and a new therapy for post-acne scars. No local study was found in literature research. Hence, any effect of this potentially very effective therapeutic modality needs to be investigated.
OBJECTIVE: "To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars".
Material \& Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will includes 60 patients which will be divided into 2 groups A \& B, 30 in each group. Group A will receive micro-needling with topical application of 2ml of human actrapid insulin. Group B will receive micro-needling with topical application of 2ml Platelet rich plasma. Face of the patient will be washed after 30 mints and patients will be strictly instructed regarding sun protection at least 1 day after the procedure. Blood glucose level will be checked prior to and 30 mints following procedure.
At monthly interval for total 4 sessions and follow up visit will be after 2 months of last session.Data will be analyzed by SPSS v25.0.
Chi-square test will be applied for qualitative variables and t-test will be used for quantitative variables.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Sheikh Zayed Medical College is the lead sponsor of 27 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml of human actrapid insulin
Procedure: micro-needling with topical human actrapid insulin
Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml Platelet rich plasma
Procedure: Micro-needling with topical Platelet rich plasma
Micro-needling with topical application of 2ml of human actrapid insulin once monthly for 4 months
Micro-needling with topical application of 2ml Platelet rich plasma once monthly for 4 months
To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars
Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 6th month after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1.Remission: It is defined as complete resolution of all scar leaving behind normal skin. 2.Improvement: It is defined as a more than 50% healing of scars ,as clinically measured by the surface area from the baseline. 3.No improvement: It is defined as less than a 50% improvement in the healing of scars, as measured clinically by the surface area from the baseline.
Time frame: Clinical assessment for efficacy will be done monthly for 6 months
Plan to share: No
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Start is estimated for Jan 2025; primary completion for Apr 2025, 3 months later.
Of 24 phase 2 interventional studies under Cicatrix, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 61. This study's planned 3 months is below that.
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Sheikh Zayed Medical College