Clinical trial NCT06590909: Fractional CO2 Laser Delivery of Topical Insulin Versus Platelet Rich Plasma in Treatment of Atrophic Post Acne Scars
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion criteria:

patients aged equal or more than 18 years with atrophic post acne scars.

Exclusion criteria:

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.

Primary outcomes:
measure: Efficacy and safety of treating atrophic post acne scars with topical insulin versus PRP combined with fractional ablative Co2 laser.
timeFrame: 5 months from the beginning of the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Szepietowska 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.
citation: Bhargava 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.