Perioral DermatitisNCT03779295
Laser Therapy for Perioral Dermatitis
A study testing Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.) and Clindamycin in people with Perioral Dermatitis, run by West Virginia University at 1 site in United States.
Trial summary
Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioral Dermatitis
- What is being tested?
- Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.) and Clindamycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 5 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- perioral dermatitis for greater than 1 month
- willing to return for follow-up visits 2 weeks, 4 weeks and 8 weeks following treatment.
Who cannot join
- skin type V or VI (due to risk of hyperpigmentation)
- pregnant
- breastfeeding
- unable to understand English
- mentally impaired
- incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University University Town Centre Dermatology Clinic
Morgantown, West Virginia, 26501
About this study
Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. The investigators hope to assess the efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one half of the patients face and having patients apply topical medication (clindamycin) to their face for 8 weeks. The side of their face that receives laser therapy will be randomized. The investigators will assess the efficacy of laser therapy by counting the number of lesions that patients have before and after laser therapy, comparing photos of patient's perioral dermatitis before and after treatment, and having patient's rate their satisfaction of the treatment.
- Conditions
- Perioral Dermatitis
- Being tested
- Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.), Clindamycin
- Keywords
- perioral dermatitis, laser therapy
- Medical subject headings
- Dermatitis, Perioral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)Device
The face will be split and randomized, one half will receive pulsed laser dye therapy.
ClindamycinDrug
The entire face (both halves) will receive clindamycin.
| Study group | Role | What they receive |
|---|---|---|
| Pulse laser therapy | Experimental | Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin Receives: Device: Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.); Drug: Clindamycin |
| Clindamycin | Experimental | Clindamycin only applied to side of face that does not receive pulse laser therapy. Receives: Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of lesions on side of the subject's face receiving laser therapy
counting number of lesions on each side of the face
Measured: initial study visit
Change in number of lesions on side of the subject's face receiving laser therapy
counting number of lesions on each side of the face
Measured: 4 weeks
Change in number of lesions on side of the subject's face receiving laser therapy
counting number of lesions on each side of the face
Measured: 8 weeks
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
counting number of lesions on each side of the face
Measured: initial study visit
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
counting number of lesions on each side of the face
Measured: 4 weeks
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
counting number of lesions on each side of the face
Measured: 8 weeks
Secondary outcomes (2)
Patient opinion of side that improved more
Patients will grade satisfaction of treatment by answering "Which side of their face improved more from treatment?" with the option of responding "the right side/the left side/they are the same."
Measured: 4 weeks
Patient opinion of side that improved more
Patients will grade satisfaction of treatment by answering "Which side of their face improved more from treatment?" with the option of responding "the right side/the left side/they are the same."
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Nov 2018
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Why it stopped: No subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioral DermatitisStudies of the same condition, open and under way.
- More trials run by West Virginia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a split face prospective trial. The face will be treated in halves. The halves will be randomized to receive topical clindamycin or PDL therapy and clindamycin. Both halves of the face will be treated with topical clindamycin. Per randomization, half of the face will be treated with pulse dye laser therapy at 595 nm, using 6.5 J/cm2, 10 mm spot size and a 6 millisecond pulse width.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Ghareeb, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779295
- Sponsor's protocol ID
- 1803028429
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2018
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Therapy for Perioral Dermatitis
- ClinicalTrials.gov ID
- NCT03779295
- Acronym / sponsor ID
- 1803028429
- Conditions
- Perioral Dermatitis
- Keywords
- perioral dermatitis, laser therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. The investigators hope to assess the efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one half of the patients face and having patients apply topical medication (clindamycin) to their face for 8 weeks. The side of their face that receives laser therapy will be randomized. The investigators will assess the efficacy of laser therapy by counting the number of lesions that patients have before and after laser therapy, comparing photos of patient's perioral dermatitis before and after treatment, and having patient's rate their satisfaction of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a split face prospective trial. The face will be treated in halves. The halves will be randomized to receive topical clindamycin or PDL therapy and clindamycin. Both halves of the face will be treated with topical clindamycin. Per randomization, half of the face will be treated with pulse dye laser therapy at 595 nm, using 6.5 J/cm2, 10 mm spot size and a 6 millisecond pulse width.
| Arm | Type | Receives |
|---|---|---|
| Pulse laser therapy | Experimental | Device: Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.), Drug: ClindamycinPulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin |
| Clindamycin | Experimental | Drug: ClindamycinClindamycin only applied to side of face that does not receive pulse laser therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older
- perioral dermatitis for greater than 1 month
- willing to return for follow-up visits 2 weeks, 4 weeks and 8 weeks following treatment.
Key exclusion criteria (6 listed)
- skin type V or VI (due to risk of hyperpigmentation)
- pregnant
- breastfeeding
- unable to understand English
- mentally impaired
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 |
|---|---|---|
| Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)The face will be split and randomized, one half will receive pulsed laser dye therapy. | Device | Pulse laser therapy |
| ClindamycinThe entire face (both halves) will receive clindamycin. | Drug | Clindamycin, Pulse laser therapy |
Primary outcome
Change in number of lesions on side of the subject's face receiving laser therapy
Time frame: initial study visit
counting number of lesions on each side of the face
Change in number of lesions on side of the subject's face receiving laser therapy
Time frame: 4 weeks
counting number of lesions on each side of the face
Change in number of lesions on side of the subject's face receiving laser therapy
Time frame: 8 weeks
counting number of lesions on each side of the face
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
Time frame: initial study visit
counting number of lesions on each side of the face
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
Time frame: 4 weeks
counting number of lesions on each side of the face
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
Time frame: 8 weeks
counting number of lesions on each side of the face
2 secondary outcomes
Patient opinion of side that improved more
Time frame: 4 weeks
Patient opinion of side that improved more
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.) and Clindamycin in people with Perioral Dermatitis, run by West Virginia University 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in number of lesions on side of the subject's face receiving laser therapy (time frame: initial study visit). The study lists 6 primary outcomes in all. 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 3 Mar 2022.