Clinical Trial: Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism

Brief Summary: Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.

Detailed Summary:

Background: Unwanted facial hair growth is a serious problem for 5-15% of all women winch affects their quality of life. In Denmark patients are offered six laser treatments covered by the public health insurance. There is a lack of good follow-up treatments to this regime that can extent the efficacy of the laser treatment. Eflornithin cream is an approved treatment for reduction of facial hair growth which has proved to give an additional efficiency when used in combination with laser treatments.The efficacy when used after laser hair removal is not known.

Aim: To investigate whether an extended efficacy of laser hair removal can be achieved with application of Eflornithin cream twice daily for six months after completion of laser treatments.

Method: in a split-face trial to apply Eflornithin cream twice daily for six months. Outcome measures are investigator evaluation, blinded on-site evaluation, patient's assessment score and clinical photos.


Sponsor: Bispebjerg Hospital

Current Primary Outcome: blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field [ Time Frame: baseline, 1, 3 and 6 months ]

Original Primary Outcome: blinded photo-evaluation of change in facial hirsutism [ Time Frame: baseline, 1, 3 and 6 months ]

Current Secondary Outcome:

  • Doctors blinded on-site evaluation of efficacy [ Time Frame: Baseline, 1, 3 and 6 months ]

    Based on a four-point scale used on both sides of the face separately:

    • no effect
    • small effect (clearly visible hairs on evaluated side)
    • large effect (minimal hair on evaluated side)
    • significant effect (none or next to no hair on evaluated side)
  • Patient's overall satisfaction [ Time Frame: Baseline, 1, 3 and 6 months ]
    Based on a VAS scale (0-10)
  • Patient's assessment of efficacy [ Time Frame: Baseline, 1, 3 and 6 months ]

    Based on a four-point scale used on both sides of the face separately:

    • no effect
    • small effect (clearly visible hairs on evaluated side)
    • large effect (minimal hair on evaluated side)
    • significant effect (none or next to no hair on evaluated side)
  • Patient's assessment of adverse events [ Time Frame: Baseline, 1, 3 and 6 months ]

    Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:

    1. mild
    2. moderate
    3. severe Other observed side effects will also be registered and rated
  • Doctor's on-site blinded assessment of adverse events [ Time Frame: Baseline, 1,3 and 6 months ]

    Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:

    1. mild
    2. moderate
    3. severe Other observed side effects will also be registered and rated
  • Patient's overall impression of efficacy [ Time Frame: Baseline, 1,3 and 6 months ]

    Assessment of the patients impression of difference between two sides of the face on a four-point scale:

    1. No difference
    2. little difference
    3. large difference
    4. significant difference, complete or almost complete clearance of hair on treated side.


Original Secondary Outcome:

  • blinded on-site evaluation of adverse events [ Time Frame: Baseline, 1, 3 and 6 months ]
  • Patient's overall satisfaction [ Time Frame: Baseline, 1, 3 and 6 months ]
  • Patient's assessment of efficacy [ Time Frame: Baseline, 1, 3 and 6 months ]
  • Patient's assessment of adverse events [ Time Frame: Baseline, 1, 3 and 6 months ]
  • blinded on-site evaluation [ Time Frame: Baseline, 1,3 and 6 months ]


Information By: Bispebjerg Hospital

Dates:
Date Received: February 14, 2013
Date Started: January 2012
Date Completion:
Last Updated: November 29, 2013
Last Verified: November 2013