DermatitisNCT05699122
Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly
A study testing Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis, Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss and Low Level Laser Therapy - Persistent erythema with intact epidermis in people with Dermatitis, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Incontinence-associated dermatitis (IAD) is defined as skin inflammation resulting from prolonged exposure to feces and/or urine, found in individuals with urinary incontinence, fecal incontinence, or both. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis, Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss and Low Level Laser Therapy - Persistent erythema with intact epidermis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2023to 30 Jun 2023
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly people who have Incontinence-Associated Dermatitis (persistent erythema with intact epidermis and erythema with signs of epidermal loss) admitted to the surgical medical clinic;
- Elderly people who have Incontinence-Associated Dermatitis (persistent erythema with intact epidermis and erythema with signs of epidermal loss) admitted to the the semi intensive.
Who cannot join
- Elderly with medical prescription for another proposed treatment for IAD that is not in the institutional protocol;
- Elderly with change in behavior proposed by the nursing team during the study period;
- Elderly in the final stage of life;
- Elderly with some hemodynamic instability due to signs of progressive organ dysfunction and/or suspected deterioration of clinical conditions with need for transfer to intensive care during the study period;
- Elderly newly diagnosed with cancer in need of transfer to oncology to start treatment during the study period; Elderly who have been newly diagnosed with COVID-19 and need to be transferred to the cohort area during the study period.
- Elderly people using product for the treatment of dermatitis associated with incontinence incompatible with the application of low-intensity laser therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Incontinence-associated dermatitis (IAD) is defined as skin inflammation resulting from prolonged exposure to feces and/or urine, found in individuals with urinary incontinence, fecal incontinence, or both. Currently, preventive and treatment measures with strong clinical evidence include gentle hygiene and application of barrier products. Justification: Low-Level Laser Therapy (LLLT) is used in the tissue repair process, due to its analgesic, anti-inflammatory and biomodulator effects, with improvement in the treatment of pressure injuries. In this way, would the use of LLLT bring better results associated with topical treatment for the management of IAD?
Read the detailed description
This is a field study, analytical, interventionist, controlled clinical trial type, randomized, double-blind and with quantitative data analysis, with the aim of comparing the topical treatment of Incontinence-Associated Dermatitis in the elderly with the topical treatment associated with Low Intensity Laser Therapy. The study population will consist of elderly people with Incontinence-Associated Dermatitis admitted to a surgical and semi-intensive medical clinic of a private, tertiary, extra-sized hospital, located in the south zone of the city of São Paulo.
Participants will be divided initially by the characteristics of IAD: persistent erythema with intact epidermis and erythema with signs of epidermis loss. Subsequently, randomization will be performed using the REDCap platform and participants will be divided into Control Group and Experimental Group.
The Control Group will receive the conventional treatment and the Experimental Group will receive the conventional treatment associated with the application of Low Intensity Laser Therapy. The conventional treatment of patients belonging to both groups will be made available in the institutional protocol of the study site for the treatment of Incontinence-Associated Dermatitis, according to its characteristics of persistent erythema with intact epidermis or erythema with signs of epidermis loss.
Persistent erythema with intact epidermis: Perform intimate hygiene with warm water (to remove excess feces and urine), apply skin cleanser without rinsing to finish cleaning, apply a thin layer of Dexpanthenol (with each diaper change), apply polymeric solution spray once a day.
Erythema with signs of epidermis loss: Perform intimate hygiene with warm water (to remove excess feces and urine), apply a leave-in skin cleanser to finish cleaning, apply powdered hydrocolloid powder and remove excess. Afterwards, apply a polymeric spray solution.
For the application of LLLT, laser therapy equipment will be used with a wavelength of 660nm and 808nm, power of 100mW, with category 3R and within the institution's calibration period.The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours.
Study participants will be followed up with daily visits for four days. On the first and fourth day of follow-up, a photographic record of the area affected by IAD will be taken and it will be assessed whether the participant has pain (verbal or numerical scale or PANAID scale) in the region affected by IAD during intimate intercourse. hygiene. Both groups will receive standardized topical treatment at the institution, according to the characteristics of the DAI and the participants of the Experimental Group will receive the application of low-intensity laser therapy in the area affected by the DAI for three days.
Follow-up may be interrupted before four days in the following cases: if the IAD is resolved, if the participant is discharged from the hospital, if the participant is transferred to intensive care or oncology during the study period, if the nursing staff changes the conduct of the proposed treatment, if the physician changes the proposed treatment or if the participant refuses to remain in the study or if the participant is diagnosed with COVID-19.
Three specialist judges, stoma therapist nurses with more than five years of experience in stoma therapy, will evaluate the photographic records of the first and last day and will evaluate: the percentage of area affected by DAI, the percentage of area affected by erythema, the percentage of area affected by erosion, percentage of area affected by denudation/ulceration, percentage of area affected by papules/satellite lesions, percentage of area affected by maceration. The evaluators will not know if the photo is from the first or the last day of treatment, they will not know the proposed treatment and they will not know about the evaluation of the other evaluator.
Through the results of the verbal and numerical scale or PANAID obtained on the first and last day of follow-up, it will be verified whether or not there was an improvement in pain during intimate hygiene in the area affected by IAD.
With the results of the specialists' evaluations of the first and last day of follow-up, it will be verified whether or not there was an improvement in the characteristics of the IAD, verifying the effectiveness of the proposed treatment.
- Conditions
- Dermatitis
- Being tested
- Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis, Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss, Low Level Laser Therapy - Persistent erythema with intact epidermis, Low Level Laser Therapy - Erythema with signs of epidermis loss
- Keywords
- Elderly, Urinary incontinence., Fecal incontinence., Diaper dermatitis., Low intensity light therapy.
- Medical subject headings
- Dermatitis, Urinary Incontinence, Fecal Incontinence, Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermisOther
Follow-up will be for 4 days, current treatment will be carried out with:
Perform intimate hygiene with warm water (to remove excess feces and urine), apply skin cleanser without rinsing to finish cleaning, apply a thin layer of Dexpanthenol (with each diaper change), apply polymeric spray solution once a day.
Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis lossOther
Follow-up will be for 4 days, current treatment will be carried out with:
Perform intimate hygiene with warm water (to remove excess feces and urine), applying a leave-in skin cleanser to finish cleaning, applying powdered hydrocolloid powder and removing excess. Afterwards, apply a polymeric spray solution.
Low Level Laser Therapy - Persistent erythema with intact epidermisOther
Follow-up will be for 4 days, current treatment will be carried out with:
Perform intimate hygiene with warm water (to remove excess feces and urine), apply skin cleanser without rinsing to finish cleaning, apply a thin layer of Dexpanthenol (with each diaper change), apply polymeric spray solution once a day.
It will be associated with the application of Low Intensity Laser Therapy. The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours.
Low Level Laser Therapy - Erythema with signs of epidermis lossOther
Follow-up will be for 4 days, current treatment will be carried out with:
Perform intimate hygiene with warm water (to remove excess feces and urine), applying a leave-in skin cleanser to finish cleaning, applying powdered hydrocolloid powder and removing excess. Afterwards, apply a polymeric spray solution.
It will be associated with the application of Low Intensity Laser Therapy. The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| The Control Group - Persistent erythema with intact epidermis | Active comparator | The Control Group - Persistent erythema with intact epidermis Receives: Other: Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis |
| The Experimental Group - Persistent erythema with intact epidermis | Experimental | The Experimental Group - Persistent erythema with intact epidermis Receives: Other: Low Level Laser Therapy - Persistent erythema with intact epidermis |
| The Control Group - Erythema with signs of epidermis loss | Active comparator | The Control Group - Erythema with signs of epidermis loss Receives: Other: Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss |
| The Experimental Group - Erythema with signs of epidermis loss | Experimental | The Experimental Group - Erythema with signs of epidermis loss Receives: Other: Low Level Laser Therapy - Erythema with signs of epidermis loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in the treatment of incontinence-associated dermatitis
Three specialist judges, stoma therapist nurses with more than five years of experience in stoma therapy, will evaluate the photographic records of the first and last day and will evaluate: the percentage of area affected by DAI, the percentage of area affected by erythema, the percentage of area affected by erosion, percentage of area affected by denudation/ulceration, percentage of area affected by papules/satellite lesions, percentage of area affected by maceration. The evaluators will not know if the photo is from the first or the last day of treatment, they will not know the proposed treatment and they will not know about the evaluation of the other evaluator.With the results of the specialists' evaluations of the first and last day of follow-up, it will be verified whether or not there was an improvement in the characteristics of the IAD, verifying the effectiveness of the proposed treatment.
Measured: 4 days
Pain assessment in the treatment of incontinence-associated dermatitis
Pain assessment can be performed with the Numeric Visual Scale with scores from 0 to 10 for conscious participants who will be able to report their pain score.
In elderly people with cognitive impairment, periods of confusion and understanding, the Pain Assessment in Advanced Dementia (PAINAD) scale will be used, which has pain intensity from 0 to 10.
Pain assessment will be performed on the first and last day of follow-up, during intimate hygiene, which is the right time to measure pain, by the principal investigator.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Lúcia de Araújo Grana, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699122
- Sponsor's protocol ID
- dermatitis
- Status last verified
- Sep 2023
- First submitted
- 2 Jan 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly
- ClinicalTrials.gov ID
- NCT05699122
- Acronym / sponsor ID
- dermatitis
- Conditions
- Dermatitis
- Keywords
- Elderly, Urinary incontinence., Fecal incontinence., Diaper dermatitis., Low intensity light therapy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jan 2023 (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.
Incontinence-associated dermatitis (IAD) is defined as skin inflammation resulting from prolonged exposure to feces and/or urine, found in individuals with urinary incontinence, fecal incontinence, or both. Currently, preventive and treatment measures with strong clinical evidence include gentle hygiene and application of barrier products. Justification: Low-Level Laser Therapy (LLLT) is used in the tissue repair process, due to its analgesic, anti-inflammatory and biomodulator effects, with improvement in the treatment of pressure injuries. In this way, would the use of LLLT bring better results associated with topical treatment for the management of IAD?
Detailed description
This is a field study, analytical, interventionist, controlled clinical trial type, randomized, double-blind and with quantitative data analysis, with the aim of comparing the topical treatment of Incontinence-Associated Dermatitis in the elderly with the topical treatment associated with Low Intensity Laser Therapy. The study population will consist of elderly people with Incontinence-Associated Dermatitis admitted to a surgical and semi-intensive medical clinic of a private, tertiary, extra-sized hospital, located in the south zone of the city of São Paulo.
Participants will be divided initially by the characteristics of IAD: persistent erythema with intact epidermis and erythema with signs of epidermis loss. Subsequently, randomization will be performed using the REDCap platform and participants will be divided into Control Group and Experimental Group.
The Control Group will receive the conventional treatment and the Experimental Group will receive the conventional treatment associated with the application of Low Intensity Laser Therapy. The conventional treatment of patients belonging to both groups will be made available in the institutional protocol of the study site for the treatment of Incontinence-Associated Dermatitis, according to its characteristics of persistent erythema with intact epidermis or erythema with signs of epidermis loss.
Persistent erythema with intact epidermis: Perform intimate hygiene with warm water (to remove excess feces and urine), apply skin cleanser without rinsing to finish cleaning, apply a thin layer of Dexpanthenol (with each diaper change), apply polymeric solution spray once a day.
Erythema with signs of epidermis loss: Perform intimate hygiene with warm water (to remove excess feces and urine), apply a leave-in skin cleanser to finish cleaning, apply powdered hydrocolloid powder and remove excess. Afterwards, apply a polymeric spray solution.
For the application of LLLT, laser therapy equipment will be used with a wavelength of 660nm and 808nm, power of 100mW, with category 3R and within the institution's calibration period.The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours.
Study participants will be followed up with daily visits for four days. On the first and fourth day of follow-up, a photographic record of the area affected by IAD will be taken and it will be assessed whether the participant has pain (verbal or numerical scale or PANAID scale) in the region affected by IAD during intimate intercourse. hygiene. Both groups will receive standardized topical treatment at the institution, according to the characteristics of the DAI and the participants of the Experimental Group will receive the application of low-intensity laser therapy in the area affected by the DAI for three days.
Follow-up may be interrupted before four days in the following cases: if the IAD is resolved, if the participant is discharged from the hospital, if the participant is transferred to intensive care or oncology during the study period, if the nursing staff changes the conduct of the proposed treatment, if the physician changes the proposed treatment or if the participant refuses to remain in the study or if the participant is diagnosed with COVID-19.
Three specialist judges, stoma therapist nurses with more than five years of experience in stoma therapy, will evaluate the photographic records of the first and last day and will evaluate: the percentage of area affected by DAI, the percentage of area affected by erythema, the percentage of area affected by erosion, percentage of area affected by denudation/ulceration, percentage of area affected by papules/satellite lesions, percentage of area affected by maceration. The evaluators will not know if the photo is from the first or the last day of treatment, they will not know the proposed treatment and they will not know about the evaluation of the other evaluator.
Through the results of the verbal and numerical scale or PANAID obtained on the first and last day of follow-up, it will be verified whether or not there was an improvement in pain during intimate hygiene in the area affected by IAD.
With the results of the specialists' evaluations of the first and last day of follow-up, it will be verified whether or not there was an improvement in the characteristics of the IAD, verifying the effectiveness of the proposed treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The Control Group - Persistent erythema with intact epidermis | Active comparator | Other: Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermisThe Control Group - Persistent erythema with intact epidermis |
| The Experimental Group - Persistent erythema with intact epidermis | Experimental | Other: Low Level Laser Therapy - Persistent erythema with intact epidermisThe Experimental Group - Persistent erythema with intact epidermis |
| The Control Group - Erythema with signs of epidermis loss | Active comparator | Other: Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis lossThe Control Group - Erythema with signs of epidermis loss |
| The Experimental Group - Erythema with signs of epidermis loss | Experimental | Other: Low Level Laser Therapy - Erythema with signs of epidermis lossThe Experimental Group - Erythema with signs of epidermis loss |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly people who have Incontinence-Associated Dermatitis (persistent erythema with intact epidermis and erythema with signs of epidermal loss) admitted to the surgical medical clinic;
- Elderly people who have Incontinence-Associated Dermatitis (persistent erythema with intact epidermis and erythema with signs of epidermal loss) admitted to the the semi intensive.
Key exclusion criteria (6 listed)
- Elderly with medical prescription for another proposed treatment for IAD that is not in the institutional protocol;
- Elderly with change in behavior proposed by the nursing team during the study period;
- Elderly in the final stage of life;
- Elderly with some hemodynamic instability due to signs of progressive organ dysfunction and/or suspected deterioration of clinical conditions with need for transfer to intensive care during the study period;
- Elderly newly diagnosed with cancer in need of transfer to oncology to start treatment during the study period; Elderly who have been newly diagnosed with COVID-19 and need to be transferred to the cohort area during the study period.
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 |
|---|---|---|
| Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermisFollow-up will be for 4 days, current treatment will be carried out with: Perform intimate hygiene with warm water (to remove excess feces and urine), apply skin cleanser without rinsing to finish cleaning, apply a thin layer of Dexpanthenol (with each diaper change), apply polymeric spray solution once a day. | Other | The Control Group - Persistent erythema with intact epidermis |
| Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis lossFollow-up will be for 4 days, current treatment will be carried out with: Perform intimate hygiene with warm water (to remove excess feces and urine), applying a leave-in skin cleanser to finish cleaning, applying powdered hydrocolloid powder and removing excess. Afterwards, apply a polymeric spray solution. | Other | The Control Group - Erythema with signs of epidermis loss |
| Low Level Laser Therapy - Persistent erythema with intact epidermisFollow-up will be for 4 days, current treatment will be carried out with: Perform intimate hygiene with warm water (to remove excess feces and urine), apply skin cleanser without rinsing to finish cleaning, apply a thin layer of Dexpanthenol (with each diaper change), apply polymeric spray solution once a day. It will be associated with the application of Low Intensity Laser Therapy. The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours. | Other | The Experimental Group - Persistent erythema with intact epidermis |
| Low Level Laser Therapy - Erythema with signs of epidermis lossFollow-up will be for 4 days, current treatment will be carried out with: Perform intimate hygiene with warm water (to remove excess feces and urine), applying a leave-in skin cleanser to finish cleaning, applying powdered hydrocolloid powder and removing excess. Afterwards, apply a polymeric spray solution. It will be associated with the application of Low Intensity Laser Therapy. The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours. | Other | The Experimental Group - Erythema with signs of epidermis loss |
Primary outcome
Efficacy in the treatment of incontinence-associated dermatitis
Time frame: 4 days
Three specialist judges, stoma therapist nurses with more than five years of experience in stoma therapy, will evaluate the photographic records of the first and last day and will evaluate: the percentage of area affected by DAI, the percentage of area affected by erythema, the percentage of area affected by erosion, percentage of area affected by denudation/ulceration, percentage of area affected by papules/satellite lesions, percentage of area affected by maceration. The evaluators will not know if the photo is from the first or the last day of treatment, they will not know the proposed treatment and they will not know about the evaluation of the other evaluator.With the results of the specialists' evaluations of the first and last day of follow-up, it will be verified whether or not there was an improvement in the characteristics of the IAD, verifying the effectiveness of the proposed treatment.
Pain assessment in the treatment of incontinence-associated dermatitis
Time frame: 4 days
Pain assessment can be performed with the Numeric Visual Scale with scores from 0 to 10 for conscious participants who will be able to report their pain score. In elderly people with cognitive impairment, periods of confusion and understanding, the Pain Assessment in Advanced Dementia (PAINAD) scale will be used, which has pain intensity from 0 to 10. Pain assessment will be performed on the first and last day of follow-up, during intimate hygiene, which is the right time to measure pain, by the principal investigator.
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 13 Sep 2023.
- 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 Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis, Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss and Low Level Laser Therapy - Persistent erythema with intact epidermis in people with Dermatitis, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 2 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 Brazil. 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 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?
Efficacy in the treatment of incontinence-associated dermatitis (time frame: 4 days). The study lists 2 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 13 Sep 2023.