NCT04197245

Brief Summary

The purpose of the study was to determine the efficacy of saline injection in post-acne atrophic scars on face. All patients with mild, moderate \& severe post-acne atrophic scars, above age of 15 years without any co-morbid conditions were included in the study. After giving local anesthesia, the isotonic saline solution has been administered intra- and sub-dermally in post-acne atrophic scars on face. The sessions were done weekly, for 12 weeks. The results were assessed by the photographs, sharquie scoring system \& Dermatology Life Quality Index score at the start and at the end of the treatment. SPSS 23 was used to analyze the data. The analysis of data showed that the response of saline injection was significant in mild and moderate scars, without any significant side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2019

Shorter than P25 for early_phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 6, 2019

Last Update Submit

January 26, 2020

Conditions

AtrophicScars

Keywords

AcneScarsDLQI

Outcome Measures

Primary Outcomes (1)

  • change in morphology of scars

    there is significant change in the morphology of scars, assessed by sharquie score for grading scars

    12 weeks

Secondary Outcomes (1)

  • change in dermatology life quality index of patients

    12 weeks

Study Arms (1)

group on treatment

EXPERIMENTAL

saline injection has been given intradermal in atrophic scars of acne on face.

Drug: saline injection therapy in post-acne atrophic scars

Interventions

saline injection therapy in post-acne atrophic scarsDRUG

saline injection contains 0.9% isotonic sodium chloride solution

Also known as: normal saline, isotonic saline
group on treatment

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Minimum age 15years
  • Maximum age 35 years
  • Both males and females with mild, moderate and severe post-acne atrophic scars on face.

You may not qualify if:

  • Hypertension
  • Cardiovascular disorders
  • Pregnancy
  • Lactation
  • Hypersensitivity to lidocaine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah postgraduate medical centre

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (3)

  • Al-Dhalimi M, Jaber A. Treatment of atrophic facial acne scars with fractional Er:Yag laser. J Cosmet Laser Ther. 2015;17(4):184-8. doi: 10.3109/14764172.2015.1007067. Epub 2015 Feb 13.

    PMID: 25588037RESULT

  • Bagherani, N, Smoller, B. Introduction of a novel therapeutic option for atrophic acne scars: saline injection therapy. Global dermatology. 2015;2(6): 225-7

    RESULT

  • Hazarika N, Archana M. The Psychosocial Impact of Acne Vulgaris. Indian J Dermatol. 2016 Sep-Oct;61(5):515-20. doi: 10.4103/0019-5154.190102.

    PMID: 27688440RESULT

MeSH Terms

Conditions

AtrophyCicatrixAcne Vulgaris

Interventions

Saline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsFibrosisPathologic ProcessesAcneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Rabia Ghafoor, FCPS

    jinnah postgraduate medical centre, karachi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 13, 2019

Study Start

January 1, 2019

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)