Acne Keloidalis NuchaeNCT00757315
NdYag Laser for Acne Keloidalis Nuchae
A study testing NdYag Laser(hair removal laser) plus topical corticosteroid and Topical corticosteroid alone in people with Acne Keloidalis Nuchae and NdYag Laser, run by Henry Ford Health System at 1 site in United States.
Trial summary
Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Keloidalis Nuchae, NdYag Laser, AKN
- What is being tested?
- NdYag Laser(hair removal laser) plus topical corticosteroid and Topical corticosteroid alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion, the subject must:
- Be at least 18 years old
- Be otherwise healthy
- Have a diagnosis of AKN with at least 10 papules/pustules and/or a non-keloidal plaque > 7 cm2 in area.
Who cannot join
- Subject must not:
- Have AKN with a keloidal plaque >3 cm in length
- Be using any other medications or undergoing any other procedures for the treatment of AKN
- Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment
- Have used any oral medications for AKN within 4 weeks of study enrollment:
- Have serious, uncontrolled medical conditions
- Be pregnant at any time during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Medical Center, New Center One
Detroit, Michigan, 48202
About this study
Official title: Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN.
- Conditions
- Acne Keloidalis Nuchae, NdYag Laser, AKN, Acne Keloidalis, AK, Dermatitis Papillaris Capillitii
- Being tested
- NdYag Laser(hair removal laser) plus topical corticosteroid, Topical corticosteroid alone
- Keywords
- acne keloidalis nuchae, NdYag laser, AKN, acne keloidalis, AK, dermatitis papillaris capillitii, folliculitis keloidalis nuchae, sycosis nuchae, acne keloid, keloidal folliculitis, lichen keloidalis nuchae, folliculitis nuchae scleroticans, sycosis framboesiformis
- Medical subject headings
- Acne Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NdYag Laser(hair removal laser) plus topical corticosteroidDevice
Also called triamcinolone
NdYag laser and topical corticosteroid are applied to one half of the scalp.
Topical corticosteroid aloneDrug
Also called Triamcinolone
topical corticosteroid alone is applied to one half of the scalp
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: NdYag Laser(hair removal laser) plus topical corticosteroid |
| 2 | Active comparator | Not described Receives: Drug: Topical corticosteroid alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation.
Measured: 6 months
Secondary outcomes (2)
Treatment tolerability as measured by 0 to 10 pain scale
Measured: 6 months
treatment safety
This will be assessed by the frequency of adverse events
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 posted23 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne Keloidalis NuchaeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H Hamzavi, MD, Principal investigator, Henry Ford Health Systems Dermatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757315
- Sponsor's protocol ID
- 5244
- Status last verified
- Mar 2013
- First submitted
- 22 Sep 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types. Dermatol Ther. 2004;17(2):177-83. doi: 10.1111/j.1396-0296.2004.04018.x.
PubMed 15113285Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4. doi: 10.4103/0378-6323.13783.
PubMed 16394358
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
- ClinicalTrials.gov ID
- NCT00757315
- Acronym / sponsor ID
- 5244
- Conditions
- Acne Keloidalis Nuchae, NdYag Laser, AKN, Acne Keloidalis, AK, Dermatitis Papillaris Capillitii
- Keywords
- acne keloidalis nuchae, NdYag laser, AKN, acne keloidalis, AK, dermatitis papillaris capillitii, folliculitis keloidalis nuchae, sycosis nuchae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Sep 2008 (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.
Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: NdYag Laser(hair removal laser) plus topical corticosteroid |
| 2 | Active comparator | Drug: Topical corticosteroid alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For inclusion, the subject must:
Key exclusion criteria (7 listed)
- Subject must not:
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 |
|---|---|---|
| NdYag Laser(hair removal laser) plus topical corticosteroidAlso: triamcinoloneNdYag laser and topical corticosteroid are applied to one half of the scalp. | Device | 1 |
| Topical corticosteroid aloneAlso: Triamcinolonetopical corticosteroid alone is applied to one half of the scalp | Drug | 2 |
Primary outcome
reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation.
Time frame: 6 months
2 secondary outcomes
Treatment tolerability as measured by 0 to 10 pain scale
Time frame: 6 months
treatment safety
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Background: PubMed 15113285Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types. Dermatol Ther. 2004;17(2):177-83. doi: 10.1111/j.1396-0296.2004.04018.x.
- Background: PubMed 16394358Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4. doi: 10.4103/0378-6323.13783.
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.
Iltefat H Hamzavi, MD principal investigator
Henry Ford Health Systems Dermatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NdYag Laser(hair removal laser) plus topical corticosteroid and Topical corticosteroid alone in people with Acne Keloidalis Nuchae and NdYag Laser, run by Henry Ford Health System at 1 site in United States.
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 4 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 29 Mar 2013. 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 United States. 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.
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?
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?
reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00757315, which also lists 2 linked publications.
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 29 Mar 2013.