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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00847795
Other study ID # RN1001-319-1005
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 18, 2009
Last updated February 18, 2009
Start date September 2002
Est. completion date June 2003

Study information

Verified date February 2009
Source Renovo
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar prevention and reduction and acceleration of healing. The trial has an additional objective to evaluate several different scar assessment techniques that can be used in future clinical trials in the prevention and reduction of scarring.


Description:

Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject receives a total of 6 wounds, two incisions and four punch biopsies. Each subject serves as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing/scarring. Healed scars from incisional wounds excised from Arm 1 and Arm 2 after 6 months for histological analysis.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 2003
Est. primary completion date June 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Clinically healthy, male and female subjects aged 60 years and over. All females will be at least 2 years post menopausal.

- Weight between 50 and 150kg or a body mass index within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 15 - 35 kg/m2.

Exclusion Criteria:

- Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.

- Subjects with a personal history of a bleeding disorder.

- Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing the acute wounds or involves the areas to be examined in this trial.

- Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.

- Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.

- Subjects with any clinically significant abnormality following review of pre trial laboratory data and physical examination (see above).

- Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, hormone replacement therapy (HRT) or anti-coagulant drugs in the thirty days prior to Day 0.

- Subjects who have evidence of drug abuse.

- Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.

- Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.

- Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group.

- In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Avotermin
Intradermal administration
Placebo
Placebo

Locations

Country Name City State
United Kingdom Renovo CTU Manchester

Sponsors (1)

Lead Sponsor Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of scar appearance by an independent panel 6 months No
Secondary Histological evaluation of wound healing 3 days No
Secondary Adverse event occurance 6 months Yes
See also
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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 NCT00594581 - Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males Phase 2
Completed NCT00984503 - Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites Phase 2
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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
Withdrawn NCT04034615 - The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars Phase 2