NCT07028567

Brief Summary

This study aimed to compare the safety and efficacy of subcision followed by diluted calcium hydroxyapatite injection versus subcision followed by the painting original chemical reconstruction of skin scars (CROSS) technique using trichloroacetic acid (TCA) for the treatment of atrophic acne scars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 11, 2025

Last Update Submit

June 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Patient satisfaction was assessed at the final follow-up visit using a 5-point Likert-type scale, comparing outcomes to the pre-treatment condition. The scale ranged from 1 (highly dissatisfied), 2 (slightly dissatisfied), 3 (neither satisfied nor dissatisfied), 4 (satisfied), to 5 (highly satisfied).

    One week

Study Arms (1)

Study group

EXPERIMENTAL

Patients with atrophic acne scars.

Drug: Calcium hydroxylapatite fillerDrug: Painting chemical reconstruction of skin scars trichloroacetic acid technique

Interventions

Patients received calcium hydroxylapatite filler (CaHA) (Radiesse®).

Study group

Patients received painting chemical reconstruction of skin scars (CROSS) trichloroacetic acid (TCA) technique.

Study group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 20 to 50 years.
  • Both sexes.
  • Patients with atrophic acne scars.

You may not qualify if:

  • Patients with Fitzpatrick skin phototypes V and VI.
  • Receiving systemic isotretinoin medication at the time of the study.
  • Active bacterial, viral or fungal infections in the treatment area.
  • Hypertrophic scarring or keloidal tendency.
  • Photosensitivity or photodermatitis.
  • Unrealistic expectation, bleeding, coagulation disorders, and any other related skin disease.
  • Pregnant or lactating females.
  • Chronic debilitating diseases such as diabetes mellitus, cardiovascular diseases, renal failure, hepatic diseases, chronic respiratory diseases or any endocrine diseases.
  • History of immunosuppressive drug intake or chemotherapy within 6 months before treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

January 1, 2023

Primary Completion

June 22, 2023

Study Completion

June 22, 2023

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations