HypertrichosisPhase 1/2NCT00371930
Photodynamic Therapy for Permanent Hair Removal
A Phase 1/2 study testing application of a dye suspension followed by a laser intervention in people with Hypertrichosis and Hirsutism, run by University of Jena at 1 site in Germany.
Trial summary
24 test persons are treated with a dye suspension followed by a laser intervention. A decrease of hair density is expected. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertrichosis, Hirsutism
- What is being tested?
- application of a dye suspension followed by a laser intervention
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Who may be able to join
- age 18-60
Who cannot join
- anormal behavior
- pregnancy
- pathologic skin conditions
- medication that my interfere with the study
- allergy against the photosensitizer
- lack of compliance
- other reasons considered important by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
24 test persons are treated with a dye suspension followed by a laser intervention. A decrease of hair density is expected.
- Conditions
- Hypertrichosis, Hirsutism
- Being tested
- application of a dye suspension followed by a laser intervention
- Medical subject headings
- Hypertrichosis, Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of a dye suspension followed by a laser interventionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrichosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Investigators
- Martin Kaatz, Dr, Principal investigator, FSU Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371930
- Sponsor's protocol ID
- 1742-03/06
- Status last verified
- Jun 2008
- First submitted
- 1 Sep 2006
- Last updated
- 4 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy for Permanent Hair Removal
- ClinicalTrials.gov ID
- NCT00371930
- Acronym / sponsor ID
- 1742-03/06
- Conditions
- Hypertrichosis, Hirsutism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of JenaUniversity, hospital or other
- First posted
- 4 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
24 test persons are treated with a dye suspension followed by a laser intervention. A decrease of hair density is expected.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-60
Key exclusion criteria (7 listed)
- anormal behavior
- pregnancy
- pathologic skin conditions
- medication that my interfere with the study
- allergy against the photosensitizer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of a dye suspension followed by a laser intervention | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
Related trials for Hypertrichosis
RecruitingObservational study
Treatment of Hypertrichosis With Intense Pulsed Light
Hypertrichosis, Hirsutism - Hypertrichosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Kaatz, Dr principal investigator
FSU Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing application of a dye suspension followed by a laser intervention in people with Hypertrichosis and Hirsutism, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Johannes Köhler (+49 3641 937359, johannes.koehler@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008.