Keloid Scarring: Treatment and Pathophysiology
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01295099 |
Recruitment Status : Unknown
Verified February 2011 by Queen Mary University of London.
Recruitment status was: Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
To clarify the mechanisms of Keloid scar formation.
Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment
Identify the genetic link with Keloid scar formation.
Quantify the psychological/social impact in keloid scarring patients
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keloid | Drug: 5- fluorouracil Radiation: radiotherapy Drug: Triamcinolone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | January 2012 |
Estimated Study Completion Date : | January 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 5-Fluorouracil
Patients with small keloidal scars to have intralesional 5FU injected
|
Drug: 5- fluorouracil
5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions |
Active Comparator: Radiotherapy
Large keloid scars undergo extralesional excision and radiotherapy
|
Radiation: radiotherapy
after complete excision of keloid they have a single session of radiotherapy |
Active Comparator: TAC |
Drug: Triamcinolone
TAC 10mg in 1ml injected intralesional |
- Keloid Scar Reduction [ Time Frame: 18 months ]Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult ( > 18 years old).
- Keloid scarring present.
- Able to understand and give informed consent.
- Patients giving informed consent to donate keloidal or non-affected skin when that is redundant after a procedure (i.e. BBR, Abdominoplasty).
- Patients with a strong familial pedigree of keloid scar formation.
Exclusion Criteria:
-
Open wound at or proximity of the lesion
- Infected lesion
- Pregnant or planning pregnancy in the near future
- Lactating (Breast Feeding)
- Abnormal renal or liver function tests
- Atrophic scars
- Patient under 18 years of age
- Immunocompromised
- OR immunosuppressed

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295099
United Kingdom | |
Barts and the London NHS Trust | |
London, UK, United Kingdom, E1 1BB |
Responsible Party: | Prof. Simon Myers, Queen Mary University of London |
ClinicalTrials.gov Identifier: | NCT01295099 |
Other Study ID Numbers: |
KS001 |
First Posted: | February 14, 2011 Key Record Dates |
Last Update Posted: | February 14, 2011 |
Last Verified: | February 2011 |
scar formation 5-FU genetic link psychological impact social impact |
Keloid Collagen Diseases Connective Tissue Diseases Cicatrix Fibrosis Pathologic Processes Triamcinolone Fluorouracil Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |