RN1001(Avotermin) in Scar Improvement Following Breast Augmentation

Status Completed

Clinical Trial Summary

This will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery. Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl of placebo solution per linear centimetre intradermally into both margins of their other breast wound. The allocation of treatment to wound (left or right) will be randomised and double blind.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00436449
Study type	Interventional
Source	Renovo
Contact
Status	Completed
Phase	Phase 2
Start date	December 2004
Completion date	January 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02672956` - Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results	N/A
Completed	`NCT02645773` - Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring	N/A
Completed	`NCT00629811` - Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women	Phase 2
Completed	`NCT00977951` - Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects	Phase 1/Phase 2
Completed	`NCT00847795` - Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.	Phase 1/Phase 2
Not yet recruiting	`NCT03213548` - Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty	N/A
Recruiting	`NCT05377723` - Abdominal Scar Improvement in Microsurgical Breast Reconstruction	N/A
Active, not recruiting	`NCT01976260` - A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars	N/A
Terminated	`NCT00432328` - Juvista (Avotermin) in Breast Reduction Surgery Scars	Phase 2
Completed	`NCT00984503` - Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites	Phase 2
Completed	`NCT00594581` - Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males	Phase 2
Recruiting	`NCT04420442` - Scar Resection and Reconstruction With Integra and Split Skin Grafts in Patients With Non-Suicidal Self-Inflicted Scars	N/A
Completed	`NCT02772289` - Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars	Phase 2
Completed	`NCT00430326` - Juvista (Avotermin) in Scars Following Varicose Vein Removal	Phase 2
Completed	`NCT00847925` - Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects	Phase 1/Phase 2
Recruiting	`NCT05787171` - Three Sutures With Different Absorption Rates for Lower Abdominal Incision	N/A
Completed	`NCT02985151` - Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy	N/A
Completed	`NCT02340325` - FS2 Safety and Tolerability Study in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT00432211` - Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.	Phase 2
Completed	`NCT00978302` - Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista)	Phase 1