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Research Question & Hypothesis: (Feasible, Interesting, Novel, Ethical & Relevant) FINER

FK506/Tacrolimus is an effective and safe treatment for keloids. Click here to access list of registered clinical trials using tacrolimus.

This service is provided by Aetna web service.

Background & Justification:

Study Design


Keloid patients visiting the department in 1 year.

Methods of recruitment (Inclusion & Exclusion Criteria)


  • Clinical diagnosis of flat keloids
  • No treatment during previous 6 months
  • Willing to participate
  • Age above 14


  • Pedunculated Keloids only
  • Pregnancy
  • Co-morbidities
  • Known allergies to ingredients

Randomisation and blinding methods

  • Randomisation Table
  • Concealment: Sachets of two similar looking ointments sequentially numbered.
  • Blinding: Allocation code with pharmacist and the HOD (for emergencies)

Primary and secondary endpoints and outcomes

  • Primary endpoint: After 4-6 weeks. Product used for 4 weeks
  • Secondary endpoint: After 3-4 months

Outcome measure:

Modified Vancouver Scar Scale:

  • Pain 0/1
  • Itching 0/1
  • Redness 0/1/2
  • Hardness 0/1/2
  • Elevation 0/1/2

All the grading points were added together and the results were evaluated into four categories according to total scores: excellent = 0, good = 1~2, fair = 3 and poor = 4~8. Maximum 8, Minimum 0 Please cite this page.

Measured at baseline and at primary and secondary end points. The improvement from baseline is recorded at both endpoints. Photographs taken during evaluation for documentation.

Type of Study:

Double Blind, Prospective, Randomised, Placebo Controlled, parallel, double arm, superiority.

Sample size:

mu1=4, mu2=1, sigma=2, 2 tailed, alpha=0.05, beta=0.80 = 7 per group.

10 per group, optimised for thesis considering attrition. Please consult your statistician

Method of data collection

3 typical lesions selected for evaluation. The given preparation applied once daily for 30 days. Auxiliary data collected: Age, Sex, Duration, Location.

Statistical analysis

Compare means of improvement at both endpoints using Mann-whitney U test. Auxiliary data is summarised using descriptive methods. Please note that the study is not powered to make any assumptions based on auxiliary data.

Timetable: N/A


  • Explain about confidentiality.
  • Explain objective of research
  • Written consent
  • Ethics committee clearance


  • FK506 inhibits the enhancing effects of transforming growth factor on collagen expression and TGF/Smad signaling in keloid fibroblasts: Implication for new therapeutic approach


Publication plan

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About Me

I have varied research interests ranging from eHealth, Health Information Exchange, Clinical Trials and Research, Contact Dermatitis, Bioinformatics, and Cosmetic Dermatology. I have work experience in Canada as an eHealth analyst, and in Dubai and India as a Specialist Dermatologist.


Bell Raj Eapen
Hamilton, ON