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Trial record 79 of 79 for:    acne AND almost AND facial

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

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ClinicalTrials.gov Identifier: NCT01817894
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):
Elisabeth Taudorf, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Hirsutism Drug: Eflornithine cream 11.5 w/w % Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
Study Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
split-face eflornithin vs. no treatment
Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months
Drug: Eflornithine cream 11.5 w/w %
Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months
Other Name: Vaniqa




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. none
    2. mild
    3. moderate
    4. 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:

    1. none
    2. mild
    3. moderate
    4. 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:

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01817894


Locations
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Denmark
Dermatological Dep Bispebjerg Hospital
Copenhagen NV, Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Elisabeth H Taudorf, MD BispbejergH

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Responsible Party: Elisabeth Taudorf, MD PhD student, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01817894     History of Changes
Other Study ID Numbers: H-2-2011-139
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013
Keywords provided by Elisabeth Taudorf, Bispebjerg Hospital:
Unwanted facial hair growth
Additional relevant MeSH terms:
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Hirsutism
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Eflornithine
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action