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.

Study Overview

• Status: Completed
• Conditions: Hirsutism
• Intervention / Treatment: Drug: Eflornithine cream 11.5 w/w %

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Copenhagen NV, Copenhagen, Denmark, 2400
      • Dermatological Dep Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Doctors blinded on-site evaluation of efficacy	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)	Baseline, 1, 3 and 6 months
Patient's overall satisfaction	Based on a VAS scale (0-10)	Baseline, 1, 3 and 6 months
Patient's assessment of efficacy	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)	Baseline, 1, 3 and 6 months
Patient's assessment of adverse events	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	Baseline, 1, 3 and 6 months
Doctor's on-site blinded assessment of adverse events	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	Baseline, 1,3 and 6 months
Patient's overall impression of efficacy	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.	Baseline, 1,3 and 6 months

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Elisabeth H Taudorf, MD, BispbejergH

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 26, 2013

Study Record Updates

• Last Update Posted (Estimate): December 2, 2013
• Last Update Submitted That Met QC Criteria: November 29, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Unwanted facial hair growth
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Virilism; Hirsutism; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Trypanocidal Agents; Ornithine Decarboxylase Inhibitors; Eflornithine
• Other Study ID Numbers: H-2-2011-139