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Completed

NCT Number: NCT01817894

Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism

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.

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Key information

Conditions

Hirsutism Hair Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Virilism

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dermatological Dep Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • habile, understands Danish
  • moderate to severe hirsutism prior to laser treatments
  • succeeded minimum five laser treatments
  • intact skin with no severe adverse events to laser treatments
  • record of current medication and androgen hormone blood profile available
  • Use of safe anti-conception (fertile women)

Exclusion criteria

  • Pregnant or lactating
  • allergy toward the content of Eflornithin cream
  • Concomitant use of immunosuppressive therapy
  • Dementia, psychiatric disease, alcoholic

Treatment and study plan

Eflornithine cream 11.5 w/w %

Drug

Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months

Other names: Vaniqa

Primary outcomes

  1. blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field

    Time frame: baseline, 1, 3 and 6 months

Secondary outcomes

  1. 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)

  2. Patient's overall satisfaction

    Time frame: Baseline, 1, 3 and 6 months

    Based on a VAS scale (0-10)

  3. 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)

  4. 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:

    • none
    • mild
    • moderate
    • severe Other observed side effects will also be registered and rated

  5. 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:

    • none
    • mild
    • moderate
    • severe Other observed side effects will also be registered and rated

  6. 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:

    • No difference
    • little difference
    • large difference
    • significant difference, complete or almost complete clearance of hair on treated side.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2013
Registry last updated
Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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