Hirsutism Clinical Trial
Official title:
Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
Verified date | November 2013 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Dermatological Dep Bispebjerg Hospital | Copenhagen NV | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital |
Denmark,
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 |
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