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

NCT ID: NCT01817894

Last Updated: 2013-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-10-31

Brief Summary

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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 Description

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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.

Conditions

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Hirsutism

Keywords

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Unwanted facial hair growth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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split-face eflornithin vs. no treatment

Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months

Group Type OTHER

Eflornithine cream 11.5 w/w %

Intervention Type DRUG

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

Interventions

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Eflornithine cream 11.5 w/w %

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

Intervention Type DRUG

Other Intervention Names

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Vaniqa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth Taudorf

MD PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisabeth H Taudorf, MD

Role: PRINCIPAL_INVESTIGATOR

BispbejergH

Locations

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Dermatological Dep Bispebjerg Hospital

Copenhagen NV, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2011-139

Identifier Type: -

Identifier Source: org_study_id