NCT06590909

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Nov 2024Jul 2027

First Submitted

Initial submission to the registry

June 28, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.6 years

First QC Date

June 28, 2024

Last Update Submit

September 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 months from the beginning of the treatment

Study Arms (1)

A prospective comparative split face study

ACTIVE COMPARATOR
Combination Product: Fractional CO2 laser assisted PDT

Interventions

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.

Also known as: topical platelet rich plasma
A prospective comparative split face study

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30101990BACKGROUND
  • 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.

    PMID: 35869826BACKGROUND
  • 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.

    PMID: 29744784BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 28, 2024

First Posted

September 19, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share