Herpes ZosterNCT04258930
Occlusion vs Standard Treatment for the Treatment of Herpes Zoster
A study testing Aluminum sulphate and calcium acetate drying soaks, Topical sterile silicone gel for wounds and Hydrocolloid dressing in people with Herpes Zoster, run by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. at 1 site in Mexico.
Trial summary
This study evaluates the addition of occlusive dressings (hydrocolloids) or topical silicone gel in the treatment of shingles (herpes zoster). One third of the participants will receive a hydrocolloid occlusive dressing, one third will receive the topical silicone gel and one third will receive the current treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Aluminum sulphate and calcium acetate drying soaks, Topical sterile silicone gel for wounds and Hydrocolloid dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 26 Feb 2020to 31 Jan 2022
- 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
- Patients with clinical diagnosis of HZ confirmed by a certified dermatologist
- Patients having maximum 72 hours from the start of the first vesicle
- Older than 18 years
Who cannot join
- Patients with dimethicone allergy
- Patients with hydrocolloid allergy
- Patients with acetaminophen allergy
- Patients with aluminium sulphate and calcium acetate allergy
- Patients with acyclovir allergy
- Pregnant women
Show all 15Show fewer
- Breastfeeding women
- Unable to give informed consent
- Patients with signs of infection over the skin rash
- Patients with disseminated HZ
- Patients with hemorrhagic HZ
- Patients with complications such as pneumonia or encephalitis
- Patients unable to apply the treatment to the affected area
- Patients with HZ-associated keratitis
- Patients whose rash is located to hairy areas that may hinder occlusion with the hydrocolloid dressing.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General Dr Manuel Gea González
Mexico City, Mexico City, 14080
Jose Contreras-Ruiz, MD, +525540003000 ext. 6704, dermayheridas@gmail.com
Adriana Lozano-Platonoff, MD, +525540003000 ext. 6704, dralozanoplatonoff@gmail.com
About this study
Official title: Randomized Comparative Open Trial of Occlusive Therapy With a Hydrocolloid or Silicone Versus Conventional Drying Treatment for the Local Care of Acute Lesions Caused by Herpes Zoster.
This study evaluates the addition of occlusive dressings (hydrocolloids) or topical silicone gel in the treatment of shingles (herpes zoster). One third of the participants will receive a hydrocolloid occlusive dressing, one third will receive the topical silicone gel and one third will receive the current treatment of the rash consisting of drying solutions (soaks).
Read the detailed description
Herpes zoster (HZ), also known shingles, is a viral disease caused by the varicella-zoster virus. It is considered a local reactivation of varicella (chicken pox). The rash of herpes zoster is characterized by vesicles that appear following a single dermatome (the territory that is innervated by one spinal nerve). These vesicles may be very painful and cause discomfort due to draining and crusting. When a person becomes sick with shingles healthcare professionals prescribe systemic (oral) treatment with antivirals (e.g. acyclovir) and pain medication according to the type and severity. To treat the local lesions caused by shingles, over the centuries, patients have been treated with drying solutions and drying powders. This practice has been passed on through the years without any evidence supporting its effectiveness, in all likelihood due to the fact that the rash is self-limited to 2 to 3 weeks. Recently, new evidence has shown that the vesicles that appear with the shingles rash are not superficial but involve deeper areas of the skin and should be considered partial thickness wounds. Since 1962, it has become clear that partial thickness wounds benefit from occlusive therapy (keeping wounds closed and avoiding drying) such as dressings and occlusive gels that keep the wound wet rather than allowing it to dry.
In this clinical trial the investigators believe that given this information, using occlusive therapy with a hydrocolloid dressing or a silicone-based gel may heal the rash of herpes zoster, decrease pain and improve the quality of life, much faster than the treatment currently used of drying the area with powders and solutions.
- Conditions
- Herpes Zoster
- Being tested
- Aluminum sulphate and calcium acetate drying soaks, Topical sterile silicone gel for wounds, Hydrocolloid dressing
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluminum sulphate and calcium acetate drying soaksOther
Also called Domeboro
Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.
Topical sterile silicone gel for woundsDevice
Also called Stratamed gel
Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.
Hydrocolloid dressingDevice
Also called Duoderm Extra-thin
Apply enough hydrocolloid dressings to cover all open areas and change every 2 to 3 days once the dressing becomes saturated (starts to drain around the borders).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Aluminum sulphate and calcium acetate drying soaks | Active comparator | Group A will receive 10 minute soaks every 8 hours with a solution prepared with aluminum sulphate and calcium acetate powder (Domeboro® (Advaita Pharmaceuticals, México)) diluted in 500 ml of clean cold water. Receives: Other: Aluminum sulphate and calcium acetate drying soaks |
| Group B: Topical sterile silicone gel for wounds | Experimental | Group B will receive topical silicone sterile gel for wounds (Stratamed gel®, (Stratapharma, Switzerland)) applied every 8 hours. Receives: Device: Topical sterile silicone gel for wounds |
| Group C: Hydrocolloid dressing | Experimental | Group C will apply an extra thin hydrocolloid dressing to all the open areas (Duoderm Extra Thin® (Convatec, USA)) with dressing changes every 48 to 72 hours depending on the amount of wound exudate. Receives: Device: Hydrocolloid dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to achieve complete healing of cutaneous lesions.
The total number of days from the beginning of the rash to the disappearance of all scabs.
Measured: Evaluation at 10 days.
Change in pain score using the Zoster Brief Pain Inventory (ZBPI)
Score reduction in the Zoster Brief Pain Inventory (ZBPI). It uses an 11-point Likert scale (0-10) to rate herpes zoster pain and discomfort for four different dimensions (worst, least, and average during the past 24 hours, and now) and herpes zoster pain and discomfort-related interference with seven items of activities of daily living and health: general activity, mood, walking ability, work, relations with others, sleep, enjoyment of life.
Measured: Evaluation at baseline, 5 days, 10 days and 40 days.
Pain reduction as per acetaminophen need
Amount of acetaminophen taken in total for pain control through the duration of the trial.
Measured: Evaluation at 40 days.
Change in the quality of life score as measured by the Dermatology Life Quality Index (DLQI)
Quality of life score improvement as measured by the Dermatology Life Quality Index (DLQI). There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Measured: Evaluation at baseline, 5 days, 10 days and 40 days.
Secondary outcomes (1)
Description and quantification of any side effect during the trial.
Presence or absence of side effects of any of the above treatments.
Measured: Evaluation at baseline, 5 days, 10 days and 40 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start26 Feb 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies 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
- Model description
- Randomized comparative open trial comparing occlusive therapy with hydrocolloid dressings versus a silicone gel vs a drying solution (standard care) to treat the rash of herpes zoster.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Contreras-Ruiz, MD, Principal investigator, Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258930
- Sponsor's protocol ID
- FNEIDAC-HZ-122-19
- Status last verified
- Feb 2020
- First submitted
- 15 Jan 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boivin G, Jovey R, Elliott CT, Patrick DM. Management and prevention of herpes zoster: A Canadian perspective. Can J Infect Dis Med Microbiol. 2010 Spring;21(1):45-52. doi: 10.1155/2010/178036.
PubMed 21358885Bader MS. Herpes zoster: diagnostic, therapeutic, and preventive approaches. Postgrad Med. 2013 Sep;125(5):78-91. doi: 10.3810/pgm.2013.09.2703.
PubMed 24113666Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18;369(3):255-63. doi: 10.1056/NEJMcp1302674.
PubMed 23863052Coplan PM, Schmader K, Nikas A, Chan IS, Choo P, Levin MJ, Johnson G, Bauer M, Williams HM, Kaplan KM, Guess HA, Oxman MN. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain. 2004 Aug;5(6):344-56. doi: 10.1016/j.jpain.2004.06.001.
PubMed 15336639Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378Greenwood JE, Wagstaff MJ, Mackie IP, Mustoe TA. Silicone action in the open wound: a hypothesis. J Burn Care Res. 2012 Jan-Feb;33(1):e17-20. doi: 10.1097/BCR.0b013e31823e68cc. No abstract available.
PubMed 22138810HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
PubMed 14087904Karlsmark T, Goodman JJ, Drouault Y, Lufrano L, Pledger GW; Cold Sore Study Group. Randomized clinical study comparing Compeed cold sore patch to acyclovir cream 5% in the treatment of herpes simplex labialis. J Eur Acad Dermatol Venereol. 2008 Nov;22(10):1184-92. doi: 10.1111/j.1468-3083.2008.02761.x. Epub 2008 May 6.
PubMed 18462303Keegan DA. Reducing pain in acute herpes zoster with plain occlusive dressings: a case report. J Med Case Rep. 2015 Apr 25;9:89. doi: 10.1186/s13256-015-0560-5.
PubMed 25907451Lin PL, Fan SZ, Huang CH, Huang HH, Tsai MC, Lin CJ, Sun WZ. Analgesic effect of lidocaine patch 5% in the treatment of acute herpes zoster: a double-blind and vehicle-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):320-5. doi: 10.1016/j.rapm.2007.02.015.
PubMed 18675742Monk EC, Benedetto EA, Benedetto AV. Successful treatment of nonhealing scalp wounds using a silicone gel. Dermatol Surg. 2014 Jan;40(1):76-9. doi: 10.1111/dsu.12366. Epub 2013 Nov 25. No abstract available.
PubMed 24267314O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.
PubMed 24030657Patel AR, Romanelli P, Roberts B, Kirsner RS. Treatment of herpes simplex virus infection: rationale for occlusion. Adv Skin Wound Care. 2007 Jul;20(7):408-12. doi: 10.1097/01.ASW.0000280199.58260.62.
PubMed 17620742Patel AR, Romanelli P, Roberts B, Kirsner RS. Herpes simplex virus: a histopathologic study of the depth of herpetic wounds. Int J Dermatol. 2009 Jan;48(1):36-40. doi: 10.1111/j.1365-4632.2009.03788.x.
PubMed 19126048Pott FS, Meier MJ, Stocco JG, Crozeta K, Ribas JD. The effectiveness of hydrocolloid dressings versus other dressings in the healing of pressure ulcers in adults and older adults: a systematic review and meta-analysis. Rev Lat Am Enfermagem. 2014 May-Jun;22(3):511-20. doi: 10.1590/0104-1169.3480.2445.
PubMed 25029065
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Open Trial of Occlusive Therapy With a Hydrocolloid or Silicone Versus Conventional Drying Treatment for the Local Care of Acute Lesions Caused by Herpes Zoster.
- ClinicalTrials.gov ID
- NCT04258930
- Acronym / sponsor ID
- FNEIDAC-HZ-122-19
- Conditions
- Herpes Zoster
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.University, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 6 Feb 2020 (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.
This study evaluates the addition of occlusive dressings (hydrocolloids) or topical silicone gel in the treatment of shingles (herpes zoster). One third of the participants will receive a hydrocolloid occlusive dressing, one third will receive the topical silicone gel and one third will receive the current treatment of the rash consisting of drying solutions (soaks).
Detailed description
Herpes zoster (HZ), also known shingles, is a viral disease caused by the varicella-zoster virus. It is considered a local reactivation of varicella (chicken pox). The rash of herpes zoster is characterized by vesicles that appear following a single dermatome (the territory that is innervated by one spinal nerve). These vesicles may be very painful and cause discomfort due to draining and crusting. When a person becomes sick with shingles healthcare professionals prescribe systemic (oral) treatment with antivirals (e.g. acyclovir) and pain medication according to the type and severity. To treat the local lesions caused by shingles, over the centuries, patients have been treated with drying solutions and drying powders. This practice has been passed on through the years without any evidence supporting its effectiveness, in all likelihood due to the fact that the rash is self-limited to 2 to 3 weeks. Recently, new evidence has shown that the vesicles that appear with the shingles rash are not superficial but involve deeper areas of the skin and should be considered partial thickness wounds. Since 1962, it has become clear that partial thickness wounds benefit from occlusive therapy (keeping wounds closed and avoiding drying) such as dressings and occlusive gels that keep the wound wet rather than allowing it to dry.
In this clinical trial the investigators believe that given this information, using occlusive therapy with a hydrocolloid dressing or a silicone-based gel may heal the rash of herpes zoster, decrease pain and improve the quality of life, much faster than the treatment currently used of drying the area with powders and solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized comparative open trial comparing occlusive therapy with hydrocolloid dressings versus a silicone gel vs a drying solution (standard care) to treat the rash of herpes zoster.
| Arm | Type | Receives |
|---|---|---|
| Group A: Aluminum sulphate and calcium acetate drying soaks | Active comparator | Other: Aluminum sulphate and calcium acetate drying soaksGroup A will receive 10 minute soaks every 8 hours with a solution prepared with aluminum sulphate and calcium acetate powder (Domeboro® (Advaita Pharmaceuticals, México)) diluted in 500 ml of clean cold water. |
| Group B: Topical sterile silicone gel for wounds | Experimental | Device: Topical sterile silicone gel for woundsGroup B will receive topical silicone sterile gel for wounds (Stratamed gel®, (Stratapharma, Switzerland)) applied every 8 hours. |
| Group C: Hydrocolloid dressing | Experimental | Device: Hydrocolloid dressingGroup C will apply an extra thin hydrocolloid dressing to all the open areas (Duoderm Extra Thin® (Convatec, USA)) with dressing changes every 48 to 72 hours depending on the amount of wound exudate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinical diagnosis of HZ confirmed by a certified dermatologist
- Patients having maximum 72 hours from the start of the first vesicle
- Older than 18 years
Key exclusion criteria (15 listed)
- Patients with dimethicone allergy
- Patients with hydrocolloid allergy
- Patients with acetaminophen allergy
- Patients with aluminium sulphate and calcium acetate allergy
- Patients with acyclovir allergy
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 |
|---|---|---|
| Aluminum sulphate and calcium acetate drying soaksAlso: DomeboroDilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed. | Other | Group A: Aluminum sulphate and calcium acetate drying soaks |
| Topical sterile silicone gel for woundsAlso: Stratamed gelApply a thick layer of silicone gel to all open areas every 8 hours until completely healed. | Device | Group B: Topical sterile silicone gel for wounds |
| Hydrocolloid dressingAlso: Duoderm Extra-thinApply enough hydrocolloid dressings to cover all open areas and change every 2 to 3 days once the dressing becomes saturated (starts to drain around the borders). | Device | Group C: Hydrocolloid dressing |
Primary outcome
Number of days to achieve complete healing of cutaneous lesions.
Time frame: Evaluation at 10 days.
The total number of days from the beginning of the rash to the disappearance of all scabs.
Change in pain score using the Zoster Brief Pain Inventory (ZBPI)
Time frame: Evaluation at baseline, 5 days, 10 days and 40 days.
Score reduction in the Zoster Brief Pain Inventory (ZBPI). It uses an 11-point Likert scale (0-10) to rate herpes zoster pain and discomfort for four different dimensions (worst, least, and average during the past 24 hours, and now) and herpes zoster pain and discomfort-related interference with seven items of activities of daily living and health: general activity, mood, walking ability, work, relations with others, sleep, enjoyment of life.
Pain reduction as per acetaminophen need
Time frame: Evaluation at 40 days.
Amount of acetaminophen taken in total for pain control through the duration of the trial.
Change in the quality of life score as measured by the Dermatology Life Quality Index (DLQI)
Time frame: Evaluation at baseline, 5 days, 10 days and 40 days.
Quality of life score improvement as measured by the Dermatology Life Quality Index (DLQI). There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
1 secondary outcome
Description and quantification of any side effect during the trial.
Time frame: Evaluation at baseline, 5 days, 10 days and 40 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 21358885Boivin G, Jovey R, Elliott CT, Patrick DM. Management and prevention of herpes zoster: A Canadian perspective. Can J Infect Dis Med Microbiol. 2010 Spring;21(1):45-52. doi: 10.1155/2010/178036.
- Background: PubMed 24113666Bader MS. Herpes zoster: diagnostic, therapeutic, and preventive approaches. Postgrad Med. 2013 Sep;125(5):78-91. doi: 10.3810/pgm.2013.09.2703.
- Background: PubMed 23863052Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18;369(3):255-63. doi: 10.1056/NEJMcp1302674.
- Background: PubMed 15336639Coplan PM, Schmader K, Nikas A, Chan IS, Choo P, Levin MJ, Johnson G, Bauer M, Williams HM, Kaplan KM, Guess HA, Oxman MN. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain. 2004 Aug;5(6):344-56. doi: 10.1016/j.jpain.2004.06.001.
- Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
- Background: PubMed 22138810Greenwood JE, Wagstaff MJ, Mackie IP, Mustoe TA. Silicone action in the open wound: a hypothesis. J Burn Care Res. 2012 Jan-Feb;33(1):e17-20. doi: 10.1097/BCR.0b013e31823e68cc. No abstract available.
- Background: PubMed 14087904HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
- Background: PubMed 18462303Karlsmark T, Goodman JJ, Drouault Y, Lufrano L, Pledger GW; Cold Sore Study Group. Randomized clinical study comparing Compeed cold sore patch to acyclovir cream 5% in the treatment of herpes simplex labialis. J Eur Acad Dermatol Venereol. 2008 Nov;22(10):1184-92. doi: 10.1111/j.1468-3083.2008.02761.x. Epub 2008 May 6.
- Background: PubMed 25907451Keegan DA. Reducing pain in acute herpes zoster with plain occlusive dressings: a case report. J Med Case Rep. 2015 Apr 25;9:89. doi: 10.1186/s13256-015-0560-5.
- Background: PubMed 18675742Lin PL, Fan SZ, Huang CH, Huang HH, Tsai MC, Lin CJ, Sun WZ. Analgesic effect of lidocaine patch 5% in the treatment of acute herpes zoster: a double-blind and vehicle-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):320-5. doi: 10.1016/j.rapm.2007.02.015.
- Background: PubMed 24267314Monk EC, Benedetto EA, Benedetto AV. Successful treatment of nonhealing scalp wounds using a silicone gel. Dermatol Surg. 2014 Jan;40(1):76-9. doi: 10.1111/dsu.12366. Epub 2013 Nov 25. No abstract available.
- Background: PubMed 24030657O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.
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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.
Jose Contreras-Ruiz, MD principal investigator
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aluminum sulphate and calcium acetate drying soaks, Topical sterile silicone gel for wounds and Hydrocolloid dressing in people with Herpes Zoster, run by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. at 1 site in Mexico.
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 15 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 28 Feb 2020. 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 Mexico. 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?
Contact Jose Contreras-Ruiz, MD (+525540003000 ext. 6704, dermayheridas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days to achieve complete healing of cutaneous lesions. (time frame: Evaluation at 10 days.). The study lists 4 primary outcomes in all. 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 NCT04258930, which also lists 19 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 28 Feb 2020.