Subcision Followed by Diluted Calcium Hydroxylapatite Inj... | NCT07028567

Studies
Subcision Followed by Diluted Calcium Hydroxylapatite Injection Versus Subcision Followed by Painting CROSS TCA Technique for the Treatment of Atrophic Acne Scars

NCT07028567

Sponsor

Tanta University

Status

Completed

Last Update Posted

Jun 19, 2025Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Subcision
Calcium Hydroxylapatite
Trichloroacetic Acid
Atrophic Acne Scar

Interventions

Calcium hydroxylapatite filler
Painting chemical reconstruction of skin scars trichloroacetic acid technique

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jun 22, 2023Actual

Completion Date

Jun 22, 2023Actual

First Submitted Date

Jun 11, 2025

First Submission Date that Met QC Criteria

Jun 18, 2025

First Posted Date

Jun 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 19, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Riham Mohamed ElSayed ElSetiha, Resident of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Atrophic scars present as depressions secondary to fibrous contractions. Subcision is a technique in which a needle is inserted under the acne scar to sever the fibrous tissue (tethers) that bind down the scar. This releases the fibrous tissue.

The original chemical reconstruction of skin scars (CROSS) technique using trichloroacetic acid (TCA) entails focal application of highly concentrated TCA (70% to 100%) with firm pressure applied to the entire atrophic area using a sharpened wooden applicator until frosting occurs.

Fillers containing hyaluronic acid, calcium hydroxyapatite, and poly-L-lactic acid are increasingly used to correct atrophic acne scarring as they augment soft tissue in variable degree and are most effective in soft rolling or boxcar scars.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Patients with atrophic acne scars.	Drug: Calcium hydroxylapatite filler Drug: Painting chemical reconstruction of skin scars trichloroacetic acid technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Calcium hydroxylapatite filler	Drug	Patients received calcium hydroxylapatite filler (CaHA) (Radiesse®).	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University		Tanta	El-Gharbia	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

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.

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.