Acne Keloidalis NuchaePhase 4NCT01548898
The Efficacy of Laser Assisted Hair Removal in the Treatment of Acne Keloidalis Nuchae; a Pilot Study
A Phase 4 study testing Nd-YAG laser in people with Acne Keloidalis Nuchae, run by Cairo University.
Trial summary
Laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in Acne Keloidalis Nuchae (AKN). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acne Keloidalis Nuchae
- What is being tested?
- Nd-YAG laser
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to May 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients suffering from AKN
Who cannot join
None listed.
About this study
Laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in Acne Keloidalis Nuchae (AKN).
- Conditions
- Acne Keloidalis Nuchae
- Being tested
- Nd-YAG laser
- Medical subject headings
- Acne Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd-YAG laserDevice
All patients received 5 sessions (4 weeks apart) of long pulsed nd-YAG laser assisted hair removal on the affected area, emitting 1064 nm, with a fluence of 35-45 J/cm2 and pulse duration 10-30 msec adjusted to skin type and hair thickness. Laser was applied to all papules and plaques.
What is being measured
The primary outcome is the main question the study is designed to answer.
Global response to treatment
Measured: 6 months
Secondary outcomes (1)
Patient satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Keloidalis NuchaeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Abdel hay, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548898
- Sponsor's protocol ID
- Nd-YAG laser in AKN
- Status last verified
- Mar 2012
- First submitted
- 29 Feb 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Laser Assisted Hair Removal in the Treatment of Acne Keloidalis Nuchae; a Pilot Study
- ClinicalTrials.gov ID
- NCT01548898
- Acronym / sponsor ID
- Nd-YAG laser in AKN
- Conditions
- Acne Keloidalis Nuchae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Mar 2012 (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.
Laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in Acne Keloidalis Nuchae (AKN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering from AKN
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nd-YAG laserAll patients received 5 sessions (4 weeks apart) of long pulsed nd-YAG laser assisted hair removal on the affected area, emitting 1064 nm, with a fluence of 35-45 J/cm2 and pulse duration 10-30 msec adjusted to skin type and hair thickness. Laser was applied to all papules and plaques. | Device | – |
Primary outcome
Global response to treatment
Time frame: 6 months
1 secondary outcome
Patient satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nd-YAG laser in people with Acne Keloidalis Nuchae, run by Cairo University.
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 0 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: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global response to treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 8 Mar 2012.