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

Phase 4

Completed

• Conditions: Hirsutism
• Interventions: Drug: Eflornithine cream 11.5 w/w %

• Registration Number: NCT01817894
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-29
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
split-face eflornithin vs. no treatment	Eflornithine cream 11.5 w/w %	Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Patient's overall satisfaction	Baseline, 1, 3 and 6 months	Based on a VAS scale (0-10)
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)
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: 1. none; 2. mild; 3. moderate; 4. severe Other observed side effects will also be registered and rated
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: 1. none; 2. mild; 3. moderate; 4. severe Other observed side effects will also be registered and rated
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: 1. No difference; 2. little difference; 3. large difference; 4. significant difference, complete or almost complete clearance of hair on treated side.

Trial Locations

Locations (1)

Dermatological Dep Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Copenhagen, Denmark