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

Hirsutism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817894
• Other study ID #: H-2-2011-139
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2013
• Last updated: November 29, 2013
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hirsutism

Intervention

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

Locations

Country	Name	City	State
Denmark	Dermatological Dep Bispebjerg Hospital	Copenhagen NV	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field		baseline, 1, 3 and 6 months	No
Secondary	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	No
Secondary	Patient's overall satisfaction	Based on a VAS scale (0-10)	Baseline, 1, 3 and 6 months	No
Secondary	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	No
Secondary	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: mild; moderate; severe Other observed side effects will also be registered and rated	Baseline, 1, 3 and 6 months	No
Secondary	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: mild; moderate; severe Other observed side effects will also be registered and rated	Baseline, 1,3 and 6 months	No
Secondary	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	No