NCT07001644

Brief Summary

The aim of this study is to evaluate and compare the efficacy and safety of microneedling and carboxytherapy either with or without platelet-rich plasma in the treatment of striae distensae rubra.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

October 1, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 17, 2025

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

May 17, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

striae distensaestriae rubramicroneedlingcarboxytherapy

Outcome Measures

Primary Outcomes (1)

  • Reduction in the size of the stria distensae rubra

    will be assessed by digital photography, actual measurement of the stria before and after treatment, and objective assessment of the percent of improvement

    group I: six sessions over 18 weeks , group II: 6 sessions over 12 weeks, followed in both groups by three months of follow up

Study Arms (2)

treated with microneedling

ACTIVE COMPARATOR

microneedling with topical application of PRP on one side of abdomen and microneedling only on the other side

Device: microneedling

treated with carboxytherapy

ACTIVE COMPARATOR

carboxytherapy with intradermal injection of PRP on one side of abdomen and carboxytherapy only on the other side

Device: Carboxytherapy

Interventions

microneedling with topical application of PRP on one side of abdomen and microneedling only on the other side.

treated with microneedling

carboxytherapy with intradermal injection of PRP on one side of abdomen and carboxytherapy only on the other side.

treated with carboxytherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients.
  • Age ranging from 18-45 years old.
  • Fitzpatrick skin type III-IV.
  • Striae distensae rubra on the abdomen (bilateral and more or less symmetrical).

You may not qualify if:

  • Patients taking immunosuppressants or having any disease affecting wound healing including diabetes.
  • Patients receiving systemic glucocorticoids for chronic health conditions.
  • Patients with chronic dermatologic diseases such as psoriasis and vitiligo.
  • Pregnant and lactating females.
  • Patients with a tendency for keloid formation.
  • Patients with endocrine disturbance.
  • Patients with autoimmune diseases, systemic diseases such as severe anemia, respiratory, cardiac, renal or liver disorder.
  • Patients with bleeding and coagulation disorders.
  • Patients who received any form of treatment for their SD in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Striae Distensae

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • professor doctor Amira Eid

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2025

First Posted

June 3, 2025

Study Start

October 1, 2022

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

June 17, 2025

Record last verified: 2024-10

Locations