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

NCT01817894 | Completed Phase 4

• 1 other identifier: H-2-2011-139
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hirsutism

Keywords

Unwanted facial hair growth

Outcome Measures

Primary Outcomes (1)

• blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field

  baseline, 1, 3 and 6 months

Secondary Outcomes (6)

• Doctors blinded on-site evaluation of efficacy

  Baseline, 1, 3 and 6 months

• Patient's overall satisfaction

  Baseline, 1, 3 and 6 months

• Patient's assessment of efficacy

  Baseline, 1, 3 and 6 months

• Patient's assessment of adverse events

  Baseline, 1, 3 and 6 months

• Doctor's on-site blinded assessment of adverse events

  Baseline, 1,3 and 6 months

Study Arms (1)

split-face eflornithin vs. no treatment

OTHER

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 %

Interventions

Eflornithine cream 11.5 w/w % DRUG

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

Also known as: Vaniqa

split-face eflornithin vs. no treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnant or lactating
• allergy toward the content of Eflornithin cream
• Concomitant use of immunosuppressive therapy
• Dementia, psychiatric disease, alcoholic

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Dermatological Dep Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Hirsutism

Interventions

Eflornithine

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Study Officials

• Elisabeth H Taudorf, MD

  BispbejergH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD student

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: March 26, 2013
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 2, 2013

Record last verified: 2013-11

Locations

DK (1)