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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01817894
Collaborator
(none)
22
Enrollment
1
Location
1
Arm
21
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
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 :
Jan 1, 2012
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • Vaniqa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field [baseline, 1, 3 and 6 months]

    Secondary Outcome Measures

    1. Doctors blinded on-site evaluation of efficacy [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 [Baseline, 1, 3 and 6 months]

      Based on a VAS scale (0-10)

    3. Patient's assessment of efficacy [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dermatological Dep Bispebjerg Hospital Copenhagen NV Copenhagen Denmark 2400

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    • Principal Investigator: Elisabeth H Taudorf, MD, BispbejergH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elisabeth Taudorf, MD PhD student, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT01817894
    Other Study ID Numbers:
    • H-2-2011-139
    First Posted:
    Mar 26, 2013
    Last Update Posted:
    Dec 2, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Elisabeth Taudorf, MD PhD student, Bispebjerg Hospital
    Unwanted facial hair growth
    Additional relevant MeSH terms:
    Hirsutism
    Eflornithine

    Study Results

    No Results Posted as of Dec 2, 2013