Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma, Capillary

Port-Wine Stain

Hemangioma

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

split-side, 1 - 5 sessions at intervals of 6 - 8 weeks

split-side, 1 -5 sessions at intervals of 6 - 8 weeks

L Nguyen, MD

L Nguyen

To compare the efficacy and safety of 532nm KTP laser and 585 nm pulsed dye laser for treating port-wine stains.

Nevus flammeus is a vascular, primarily capillary malformation visible from birth on. In rare cases, it may also affect venous and/or arterial vascular systems of the skin or other organs \[1\]. It occurs in 0.3%-0.5% of the population \[1\], i.e. in about 3-4 out of 1000 newborns, and is thus the most frequent vascular malformation in children. The cause is a permanent dilatation of the capillary vessels, which is caused by a lack of sympathetic nerve fibers or a lower density of the same.

First-line therapy of port-wine stains consists of laser treatment with the long-pulsed dye laser \[2\] with a wavelength of 595nm. Treatment must be performed at least 10 times at intervals of about 8 weeks and leads to lightening and reduction of lesions. In recent years, problems have often arisen in care of port-wine stain patients because dye lasers often failed due to the instability of technology, resulting in treatment delays. Novel long-pulsed KTP lasers may be a sufficient alternative to pulsed dye lasers in treatment of port-wine stains.

KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

Potassium Tetanyl Phosphate Laser vs Pulsed Dye Laser for Treating Port-Wine Stains - A Prospective, Split-Side Study

assessment scale 1 - 7 (normal skin - dark purple) evaluated by physician and blinded investigator

assessment scale 1 - 6 (very - not at all) evaluated by subjects

Universitätsklinikum Hamburg-Eppendorf

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes

PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses

Pulsed-dye laser (PDL) treatment at one of two settings.

PDL Treatment

S. I. Brian Jiang, MD

This is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. The purpose of this study is to determine whether the use of the pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma.

Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. It has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.

Pilot Study of PDL to Treat BCC and SCCIS

A Pilot Study to Examine the Effectiveness of 595nM Pulsed Dye Lasers in the Treatment of Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ

Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance).

University of California, San Diego

Clinical Professor of Dermatology

Control

PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes

PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.

PDL Setting 1

PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses

PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.

PDL Setting 2

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

S. Brian Jiang

Tumor Clearance

Overall Study

Symptoms and General Pathology

Rare Diseases

Recurrence

Papilloma

Laryngeal Papillomatosis

Antineoplastic Agents

All Drugs and Chemicals

3,3'-diindolylmethane

Protective Agents

once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects

once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

diindolylmethane (DIM)

585 nm pulsed dye laser

Zhi Wang, MD

This study will determine efficacy of a new and combined treatment of laryngeal recurrent respiratory papillomatosis (RRP), by using a 585 nm pulsed dye laser (PDL) and a dietary supplement, diindolylmethane (DIM). We will compare this new treatment with PDL-only, in a total of 30 children (15 of each treatment), to determine whether this combined treatment would be effective and safe in preventing the RRP recurrence. This is the first study to combine PDL technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.

Previous studies have demonstrated that PDL can be used to remove lesions on the vocal cords and elsewhere in the throat causing less damage to surface tissues than other commonly used lasers. In our proposed clinical study, we seek to compare treatment efficacy for RRP by combining PDL with DIM, versus PDL-only treatment, in a total of 30 children with laryngeal papilloma. We will determine whether this combined treatment would be effective and safe in preventing or delaying the RRP recurrence while preserving voice quality. 30 children will be divided randomly into two treatment groups, 15 in each. The experimental group will receive one-time PDL treatment, followed by 3-month oral administration of DIM and an additional 12 months with no treatment. The other group will be treated with PDL-only, as a control, and take a placebo pill for 3 months. All of the patients will be followed for a total of 15 months. We will compare lesion recurrence and laboratory tests between the two groups, to determine efficacy and safety of the new treatment. This is the first study to combine new PDL laser technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.

laser only vs laser+ a dietary agent (DIM)

treatment to be selected based on a randomized number table, blinded to participants

New Therapy of Laryngeal Papilloma In Children

Voice Preserving Therapy of Laryngeal Papilloma In Children

no such meaningful data available due to insufficient recruitment

vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery

determine side-effect by comparing Estradiol level in blood before and after treatment

National Institute on Deafness and Other Communication Disorders (NIDCD)

Boston University

Professor and Director

PDL+DIM Pill

once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

PDL+Placebo Pill

once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects

diindolylmethane (DIM): 3-month DIM

585 nm pulsed dye laser: once-time PDL

once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

585 nm pulsed dye laser: once-time PDL

Age, Categorical

United States

Region of Enrollment

There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.

Intervention

Placebo

participants received at least one of two interventions

Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months

failure for any meaningful analysis as only 1 participant in this study

Estradiol Level in Blood Pre Treatment

Estradiol Level in Blood Post Treatment

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

endoscopic treatment with once-time PDL radiation at 6.0-8.0 J on laryngeal papilloma, followed by oral taking of 9-month Celebrex (100mg, BID), in 15 subjects

once-time and routine surgery, with either of carbon dioxide (CO2) laser radiation at 10.0-20.0 W or "cold" surgery with microinstruments, in 15 subjects

oral taking of Celebrex (100 mg, BID) for 9 months

Celebrex

once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J

once-time surgery to remove laryngeal papilloma

CO2 laser or microsurgery

Wang Zhi, M.D

Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP.

RRP and its surgeries usually involves the vocal cords or other regions of the larynx, thereby, resulting in a poor voice. Our previous studies have shown the efficacy and safety of a microvascular targeting technique (MVT) for RRP treatment using the 585 nm PDL. This technique provides a less traumatic alternative to surgery. However, postoperative recurrence of lesions still remains a problem because of microvascular regrowth. This study is a continuation of our effort to develop a new and less traumatic treatment for RRP. In this study, we will develop a new, combined RRP treatment with PDL and Celebrex. We will determine if Celebrex, a newly developed inhibitor of COX-2, can provide a long-term inhibitory effect on RRP through its anti-angiogenic activity and the synergic effect produced with the laser therapy. The hypothesis is that postoperative administration of Celebrex will provide a long-term inhibitory effect on microvascular regrowth and on COX-2 enzyme, thereby, preventing RRP from recurring after the PDL therapy. Our specific aim in this study is to determine the synergic effect between PDL and Celebrex and long-term efficacy of Celecoxib in preventing postoperative RRP recurrence. We will compare this new combined strategy with traditional treatments in 30 adult patients. This is the first time to combined this new laser MVT technique with a COX-2 inhibitor for microvascular targeting therapy of RRP. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP and will be safe and convenient enough for use in out-patient treatment.

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Voice-preserving Treatment of Laryngeal Papilloma

Criteria for the recurrence: the site scoring \>4, plus visible lesion found in \>50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.

The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.

Others: laser and surgery complications for 12 months

Experiment

treated with routine surgery (CO2 laser or "cold" microsurgery), in 15 cases

treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases

Experimental

We failed to recruit a total of 30 cases, due to (1) This disease is relative less common in clinic; and (2) particularly, more and more of patients now had a serious concern in safety of Celebrex due to news and warnings to public in recent years.

Dr. Zhi Wang

treated with both of once-time PDL and 9-month Celebrex

Time Course (Month) With Papilloma Recurrence During 12-month Follow up

treated with once-time routine surgery (CO2 laser or "cold" microsurgery)

treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months

Experienment

The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.

Number of Case With Papilloma Recurrence During a 12-month Follow up

once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or "cold" surgery with micro-instruments), in 15 subjects

once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months

Pharmaceutical Solutions

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Ophthalmic Solutions

Propranolol

Adrenergic beta-Antagonists

Timolol

Maleic acid

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the timolol arm will receive twice daily topical application of a physician-specified amount of timolol maleate 0.5% ophthalmic solution (hereby referred to as topical timolol) for up to six months.

After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the observation arm will be followed at study visits according to protocol.

After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the pulsed dye laser arm will receive a series of six weekly to semi-weekly laser treatments treatments for up to 6 treatments with potential for reduced number of treatments if the hemangioma completely resolves. A 595-nm pulsed-dye laser (PDL, V-beam Perfecta, Candela Corp, Wayland, MA) with a dynamic cooling device (DCD) will be utilized for all treatments. This device is cleared by the FDA for clinical treatment of vascular lesions.

Timolol maleate 0.5% ophthalmic solution will be used. The dose will be 1 drop per square centimeter of hemangioma, rubbed into the area by the parent/guardian twice daily. The intent is to cover the entire lesion without excess of medication. Therefore, the dose can be lowered from 1 drop/cm2 at the discretion of the investigators, but not increased. This dose should not have significant systemic side effects given that the normal systemic intravenous dose for propanolol is 2mg/kg/day and there would be much less systemic absorption if the solution is applied topically. It is well established that the stratum corneum greatly slows the transport of timolol.

topical timolol maleate

A 595-nm PDL (V-beam Perfecta, Candela Corp, Wayland, MA, USA) with a dynamic cooling device (DCD) will be utilized for all treatments. This device is cleared by the FDA for clinical treatment of vascular lesions. Protective eyewear for patient and all participants in the treatment room will be provided. A spot size of 7 or 10 mm will be used with an average fluence (energy delivered per unit area, in J/cm2) of 9 J/cm2 (range 8-10.0 J/cm2). Fluence will vary according to patient and hemangioma characteristics, including age, skin type, location, lesion thickness and response to treatment. A 30-50 ms cryogen spray cooling (CSC) duration will precede the laser pulse duration of 0.4 ms.

Pulsed dye laser

Thanh Nga T Tran, MD PhD

Yakir Levin, MD

Ray H Jalian, MD

R. Rox Anderson, MD

Kelly Stankiewicz, MD

The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects.

Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through the body. No one knows what causes blood vessels to group together. Most birthmarks don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually disappear within the first few months to years of life. These birthmarks tend to disappear spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's health, which occurs in about 1 in 3 children with hemagiomas.

Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug Administration (FDA) for treating hemangioma.

The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas have received timolol maleate. The results so far show that timolol maleate may be helpful and safe in treating hemangiomas in infants.

An important question being tested in this study is whether pulsed-dye laser or timolol maleate can prevent hemangioma from growing when used very early after birth.

Hemangiomas affect 5-10% of all children born in the United States and up to 20% of premature infants, with a higher incidence in girls. Most infantile hemangiomas (IHs) appear within a few weeks of birth, grow rapidly for months to years and eventually involute. "Benign neglect" (no treatment) is therefore recommended by most pediatricians. However, about 1/3 of cases (2-3% of all children born in the US) eventually require medical or surgical interventions for hemangiomas due to blocked vision, problems with breathing, feeding, pain, ulceration, infection, profuse bleeding or disfigurement. None of the interventions are benign. Occasionally, hemangiomas may be fatal.

The broad objective of this study is to prevent injury and disfigurement of millions of children per year by developing a very safe, effective, and non-invasive treatment that inhibits the growth of cutaneous hemangiomas in newborns. Historically, pulsed dye laser has been known to bea very effective and safe treatment for hemangiomas; however, this treatment modality has not been studied for the treatment of very early hemangiomas. Recently, systemic beta-blockade with propanolol has also shown remarkable results in treating threatening hemangiomas. However, systemic propanolol is not benign and requires inpatient monitoring for cardiac side effects. Topical beta-blocker has been demonstrated in a case report to prevent the growth of infantile eyelid hemangioma. We propose a prospective, single blinded, randomized study of pulsed dye laser (PDL) and topical beta-blocker solution (timolol maleate ophthalmic gel forming solution) in the treatment of very early hemangiomas. Specifically the efficacy, side effects and outcome of PDL and timolol will be compared with no treatment, the present standard of care for early stage hemangiomas. The extent to which early laser treatment or topical timolol treatment prevents tumor growth and the need for future medical or surgical treatments will be determined. Infants will be recruited from the pediatric and neonatal practices at Massachusetts General Hospital, and randomized to receive either: (1) a series of weekly to semi-weekly laser treatments, (2) twice daily topical application of timolol ophthalmic gel-forming solution for six weeks, or (3) no treatment. Hemangiomas will be assessed clinically and with digital photography for serial repeated measures of hemangioma size at each study visit. A panel of blinded evaluators will also provide assessment from photographs. Response, side effects and need for additional treatments will be recorded for up to 2 years after PDL and topical timolol treatment. This clinical trial fills a large gap in evidence-based medical therapy for IHs. If indeed early laser treatment of hemangiomas with PDL or topical timolol, both relatively harmless treatments, can eliminate the potential for complications by treating hemangiomas prior to the growth phase, then this trial would present an attractive solution for the problem of when and how to treat.

A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn

Preventing Growth of Hemangioma Tumors in Newborn: A Prospective Randomized Clinical Study

The primary outcome measurement will be the proportion of lesions that are completely clear or with minimum residual signs (defined as faint macular erythema with no palpable component). Three independent assessors (blinded to patient allocation) will be asked to evaluate photographs at each study visit compared to baseline using a 100-mm visual analog scale (VAS). Improvement in lesion size, thickness and color relative to baseline will be assessed by three independent observers.

Proportion of parents who consider their children to have a cosmetically acceptable outcome, functional improvement, need for additional treatment and any adverse reactions arising from PDL treatment or timolol treatment or occurring as a natural progression of the hemangioma including hyper- or hypo- pigmentation, ulceration, atrophy and hypertrophic scarring, pain associated with ulceration, infection, bleeding, and requirement for intra-lesional or systemic steroids or any other additional treatment will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
KTP Laser vs Pulsed Dye Laser for Port-Wine Stains	NCT05771311	Port-Wine Stain	KTP PDL	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Pilot Study of PDL to Treat BCC and SCCIS	NCT01245972	Basal Cell Carc... Squamous Cell C...	PDL Treatment	18 Years -	University of California, San Diego
Pilot Study of PDL to Treat BCC and SCCIS	NCT01245972	Basal Cell Carc... Squamous Cell C...	PDL Treatment	18 Years -	University of California, San Diego
New Therapy of Laryngeal Papilloma In Children	NCT00591305	Papilloma	diindolylmethan... 585 nm pulsed d...	10 Years - 21 Years	Boston University
Pilot Study of PDL to Treat BCC and SCCIS	NCT01245972	Basal Cell Carc... Squamous Cell C...	PDL Treatment	18 Years -	University of California, San Diego
Celebrex (Celecoxib) Treatment of Laryngeal Papilloma	NCT00592319	Laryngeal Papil...	Celebrex PDL CO2 laser or mi...	18 Years - 64 Years	Boston University
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn	NCT01873131	Hemangioma	topical timolol... Pulsed dye lase...	- 3 Months	Massachusetts General Hospital

Spots Global Cancer Trial Database for pdl

Every month we try and update this database with for pdl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pdl

Every month we try and update this database with for pdl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pdl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.