Hand EczemaNCT01591785
Treatment of Staphylococcus Aureus Colonization in Hand Eczema
A study testing Retapamulin 1% ointment in people with Hand Eczema and Foot Eczema, run by Gary Goldenberg at 1 site in United States.
Trial summary
Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In adults, eczema commonly localizes to the hands or feet. Several studies have implicated bacterial contamination, especially with Staphylococcus aureus (S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Eczema, Foot Eczema
- What is being tested?
- Retapamulin 1% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female subjects at least 18 years of age with a clear diagnosis of moderate-to-severe hand or hand/foot dermatitis.
- Subjects must be in general good health as confirmed by a medical history.
- Subjects must be capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- At the Baseline Visit, Subjects must have a Physician's Global Assessment (PGA) of at least 3 (moderate severity).
- Subject must be willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up period periods and comply with all study requirements.
- If a subject is a female of childbearing potential she must have a negative urine pregnancy test prior to study treatment initiation and must agree to use an approved method of birth control during the study period (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrhea for at least one year) or surgically sterile (tubal ligation and/or hysterectomy) females are categorized as non-childbearing potential.
Who cannot join
- Non-English speaking subjects
- Females who are pregnant, breast feeding, or attempting to conceive.
- Subjects with a history of known or suspected intolerance to any of the excipients of retapamulin 1% ointment or clobetasol propionate 0.05% foam.
- Subjects who have used any topical corticosteroids, topical antibiotics, topical immunosuppressants, other topical therapies (tar, calcineurin inhibitors), or phototherapy (PUVA, UVB) within eight weeks of the Baseline Visit.
- Subjects who have used any systemic corticosteroids, systemic antibiotics, or systemic immunosuppressants therapies within eight weeks of the Baseline Visit.
- Subjects with any overt signs of skin atrophy, telangiectasias, and/or striae in the target area(s).
Show all 9Show fewer
- Subjects with any active skin malignancy.
- Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study period.
- Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment for atopic dermatitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: An Investigator-Initiated Study: Treatment of Staphylococcus Aureus Colonization in Hand Eczema Decreases Severity of Disease
Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In adults, eczema commonly localizes to the hands or feet. Several studies have implicated bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor in atopic dermatitis, as infection with this bacteria correlates with disease severity. No trial to date has investigated how to treat S. aureus infection in adults with hand or hand/foot dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet, the investigators expect to have a significant clearance rate of s. aureus infection. The investigators believe that treating the bacterial infection along with treating the condition with a topical corticosteroid will significantly decrease the severity of hand/foot dermatitis in our study population.
Read the detailed description
Primary Study Objectives:
- To evaluate the efficacy of retapamulin 1% ointment with clobetasol propionate 0.05% foam versus vehicle ointment with clobetasol propionate 0.05% foam as a treatment regimen for hand or hand/foot atopic dermatitis.
- To evaluate the incidence of intranasal and hand/foot S aureus carriage rates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
- To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
Primary and secondary endpoints will be analyzed by appropriate statistical models by a qualified statistician. Any results of this pilot study will be treated as exploratory and hypothesis generating.
- Conditions
- Hand Eczema, Foot Eczema
- Being tested
- Retapamulin 1% ointment, Placebo
- Keywords
- Hand, Foot, Eczema, Atopic Dermatitis
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retapamulin 1% ointmentDrug
Also called Altabax and Olux Foam
Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days
PlaceboDrug
Also called Petroleum jelly
Placebo ointment for 5 days AND clobetasol propionate foam for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Retapamulin 1% ointment | Active comparator | Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days Receives: Drug: Retapamulin 1% ointment |
| Placebo ointment | Placebo comparator | Placebo ointment for 5 days AND clobetasol propionate foam for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With PGA of 0 or 1
Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis)
1 = Almost clear (just perceptible erythema and papulation/infiltration)
Measured: Day 15
Number of Participants With PGA of 0 or 1
Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis)
1 = Almost clear (just perceptible erythema and papulation/infiltration)
Measured: Day 28
Secondary outcomes (2)
Staph Aureus Culture Results
The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 15 compared to baseline
Measured: Day 15
Staph Aureus Culture Results
The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 28 compared to baseline
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hand EczemaStudies 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, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary Goldenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gary Goldenberg, Icahn School of Medicine at Mount Sinai
- Investigators
- Gary Goldenberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591785
- Sponsor's protocol ID
- GCO 11-0038
- Status last verified
- Dec 2020
- First submitted
- 30 Apr 2012
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meding B, Lantto R, Lindahl G, Wrangsjo K, Bengtsson B. Occupational skin disease in Sweden--a 12-year follow-up. Contact Dermatitis. 2005 Dec;53(6):308-13. doi: 10.1111/j.0105-1873.2005.00731.x.
PubMed 16364116Williams RE, Gibson AG, Aitchison TC, Lever R, Mackie RM. Assessment of a contact-plate sampling technique and subsequent quantitative bacterial studies in atopic dermatitis. Br J Dermatol. 1990 Oct;123(4):493-501. doi: 10.1111/j.1365-2133.1990.tb01455.x.
PubMed 2095181Hanifin JM, Rogge JL. Staphylococcal infections in patients with atopic dermatitis. Arch Dermatol. 1977 Oct;113(10):1383-6.
PubMed 911165Leyden JJ, Marples RR, Kligman AM. Staphylococcus aureus in the lesions of atopic dermatitis. Br J Dermatol. 1974 May;90(5):525-30. doi: 10.1111/j.1365-2133.1974.tb06447.x. No abstract available.
PubMed 4601016Jensen JM, Folster-Holst R, Baranowsky A, Schunck M, Winoto-Morbach S, Neumann C, Schutze S, Proksch E. Impaired sphingomyelinase activity and epidermal differentiation in atopic dermatitis. J Invest Dermatol. 2004 Jun;122(6):1423-31. doi: 10.1111/j.0022-202X.2004.22621.x.
PubMed 15175033Arikawa J, Ishibashi M, Kawashima M, Takagi Y, Ichikawa Y, Imokawa G. Decreased levels of sphingosine, a natural antimicrobial agent, may be associated with vulnerability of the stratum corneum from patients with atopic dermatitis to colonization by Staphylococcus aureus. J Invest Dermatol. 2002 Aug;119(2):433-9. doi: 10.1046/j.1523-1747.2002.01846.x.
PubMed 12190867Komatsu N, Saijoh K, Kuk C, Liu AC, Khan S, Shirasaki F, Takehara K, Diamandis EP. Human tissue kallikrein expression in the stratum corneum and serum of atopic dermatitis patients. Exp Dermatol. 2007 Jun;16(6):513-9. doi: 10.1111/j.1600-0625.2007.00562.x.
PubMed 17518992Sandilands A, Terron-Kwiatkowski A, Hull PR, O'Regan GM, Clayton TH, Watson RM, Carrick T, Evans AT, Liao H, Zhao Y, Campbell LE, Schmuth M, Gruber R, Janecke AR, Elias PM, van Steensel MA, Nagtzaam I, van Geel M, Steijlen PM, Munro CS, Bradley DG, Palmer CN, Smith FJ, McLean WH, Irvine AD. Comprehensive analysis of the gene encoding filaggrin uncovers prevalent and rare mutations in ichthyosis vulgaris and atopic eczema. Nat Genet. 2007 May;39(5):650-4. doi: 10.1038/ng2020. Epub 2007 Apr 8.
PubMed 17417636Haslund P, Bangsgaard N, Jarlov JO, Skov L, Skov R, Agner T. Staphylococcus aureus and hand eczema severity. Br J Dermatol. 2009 Oct;161(4):772-7. doi: 10.1111/j.1365-2133.2009.09353.x. Epub 2009 Jul 3.
PubMed 19575755Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
PubMed 19403473Naderer OJ, A.M., Roberts K, et al. , Nasal Decolonization of persistent Staphylococcus aureus carriers with twice daily application of retapamulin ointment, 1%, for 3 or 5 days. , in Presented at the joint 48th annual interscience conference on antimicrobial agents adn chemotherapy at the 46th Annual Meeting of Infectious Diseases Society of America. 2008: Washington DC.
Haddican M, Linkner RV, Singer G, Jim SC, Gagliotti M, Goldenberg G. Retapamulin 1% Ointment and Clobetasol Propionate 0.05% Foam is More Efficacious than Vehicle Ointment and Clobetasol 0.05% Propionate Foam in the Treatment of Hand/Foot Dermatitis: A Single Center, Randomized, Double-blind Study. J Clin Aesthet Dermatol. 2014 Jul;7(7):32-6.
PubMed 25053981
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Study: Treatment of Staphylococcus Aureus Colonization in Hand Eczema Decreases Severity of Disease
- ClinicalTrials.gov ID
- NCT01591785
- Acronym / sponsor ID
- GCO 11-0038
- Conditions
- Hand Eczema, Foot Eczema
- Keywords
- Hand, Foot, Eczema, Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gary GoldenbergUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In adults, eczema commonly localizes to the hands or feet. Several studies have implicated bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor in atopic dermatitis, as infection with this bacteria correlates with disease severity. No trial to date has investigated how to treat S. aureus infection in adults with hand or hand/foot dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet, the investigators expect to have a significant clearance rate of s. aureus infection. The investigators believe that treating the bacterial infection along with treating the condition with a topical corticosteroid will significantly decrease the severity of hand/foot dermatitis in our study population.
Detailed description
Primary Study Objectives:
- To evaluate the efficacy of retapamulin 1% ointment with clobetasol propionate 0.05% foam versus vehicle ointment with clobetasol propionate 0.05% foam as a treatment regimen for hand or hand/foot atopic dermatitis.
- To evaluate the incidence of intranasal and hand/foot S aureus carriage rates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
- To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
Primary and secondary endpoints will be analyzed by appropriate statistical models by a qualified statistician. Any results of this pilot study will be treated as exploratory and hypothesis generating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retapamulin 1% ointment | Active comparator | Drug: Retapamulin 1% ointmentRetapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days |
| Placebo ointment | Placebo comparator | Drug: PlaceboPlacebo ointment for 5 days AND clobetasol propionate foam for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects at least 18 years of age with a clear diagnosis of moderate-to-severe hand or hand/foot dermatitis.
- Subjects must be in general good health as confirmed by a medical history.
- Subjects must be capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- At the Baseline Visit, Subjects must have a Physician's Global Assessment (PGA) of at least 3 (moderate severity).
- Subject must be willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up period periods and comply with all study requirements.
Key exclusion criteria (9 listed)
- Non-English speaking subjects
- Females who are pregnant, breast feeding, or attempting to conceive.
- Subjects with a history of known or suspected intolerance to any of the excipients of retapamulin 1% ointment or clobetasol propionate 0.05% foam.
- Subjects who have used any topical corticosteroids, topical antibiotics, topical immunosuppressants, other topical therapies (tar, calcineurin inhibitors), or phototherapy (PUVA, UVB) within eight weeks of the Baseline Visit.
- Subjects who have used any systemic corticosteroids, systemic antibiotics, or systemic immunosuppressants therapies within eight weeks of the Baseline Visit.
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 |
|---|---|---|
| Retapamulin 1% ointmentAlso: Altabax and Olux FoamRetapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days | Drug | Retapamulin 1% ointment |
| PlaceboAlso: Petroleum jellyPlacebo ointment for 5 days AND clobetasol propionate foam for 14 days | Drug | Placebo ointment |
Primary outcome
Number of Participants With PGA of 0 or 1
Time frame: Day 15
Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)
Number of Participants With PGA of 0 or 1
Time frame: Day 28
Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)
2 secondary outcomes
Staph Aureus Culture Results
Time frame: Day 15
Staph Aureus Culture Results
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16364116Meding B, Lantto R, Lindahl G, Wrangsjo K, Bengtsson B. Occupational skin disease in Sweden--a 12-year follow-up. Contact Dermatitis. 2005 Dec;53(6):308-13. doi: 10.1111/j.0105-1873.2005.00731.x.
- Background: PubMed 2095181Williams RE, Gibson AG, Aitchison TC, Lever R, Mackie RM. Assessment of a contact-plate sampling technique and subsequent quantitative bacterial studies in atopic dermatitis. Br J Dermatol. 1990 Oct;123(4):493-501. doi: 10.1111/j.1365-2133.1990.tb01455.x.
- Background: PubMed 911165Hanifin JM, Rogge JL. Staphylococcal infections in patients with atopic dermatitis. Arch Dermatol. 1977 Oct;113(10):1383-6.
- Background: PubMed 4601016Leyden JJ, Marples RR, Kligman AM. Staphylococcus aureus in the lesions of atopic dermatitis. Br J Dermatol. 1974 May;90(5):525-30. doi: 10.1111/j.1365-2133.1974.tb06447.x. No abstract available.
- Background: PubMed 15175033Jensen JM, Folster-Holst R, Baranowsky A, Schunck M, Winoto-Morbach S, Neumann C, Schutze S, Proksch E. Impaired sphingomyelinase activity and epidermal differentiation in atopic dermatitis. J Invest Dermatol. 2004 Jun;122(6):1423-31. doi: 10.1111/j.0022-202X.2004.22621.x.
- Background: PubMed 12190867Arikawa J, Ishibashi M, Kawashima M, Takagi Y, Ichikawa Y, Imokawa G. Decreased levels of sphingosine, a natural antimicrobial agent, may be associated with vulnerability of the stratum corneum from patients with atopic dermatitis to colonization by Staphylococcus aureus. J Invest Dermatol. 2002 Aug;119(2):433-9. doi: 10.1046/j.1523-1747.2002.01846.x.
- Background: PubMed 17518992Komatsu N, Saijoh K, Kuk C, Liu AC, Khan S, Shirasaki F, Takehara K, Diamandis EP. Human tissue kallikrein expression in the stratum corneum and serum of atopic dermatitis patients. Exp Dermatol. 2007 Jun;16(6):513-9. doi: 10.1111/j.1600-0625.2007.00562.x.
- Background: PubMed 17417636Sandilands A, Terron-Kwiatkowski A, Hull PR, O'Regan GM, Clayton TH, Watson RM, Carrick T, Evans AT, Liao H, Zhao Y, Campbell LE, Schmuth M, Gruber R, Janecke AR, Elias PM, van Steensel MA, Nagtzaam I, van Geel M, Steijlen PM, Munro CS, Bradley DG, Palmer CN, Smith FJ, McLean WH, Irvine AD. Comprehensive analysis of the gene encoding filaggrin uncovers prevalent and rare mutations in ichthyosis vulgaris and atopic eczema. Nat Genet. 2007 May;39(5):650-4. doi: 10.1038/ng2020. Epub 2007 Apr 8.
- Background: PubMed 19575755Haslund P, Bangsgaard N, Jarlov JO, Skov L, Skov R, Agner T. Staphylococcus aureus and hand eczema severity. Br J Dermatol. 2009 Oct;161(4):772-7. doi: 10.1111/j.1365-2133.2009.09353.x. Epub 2009 Jul 3.
- Background: PubMed 19403473Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
- BackgroundNaderer OJ, A.M., Roberts K, et al. , Nasal Decolonization of persistent Staphylococcus aureus carriers with twice daily application of retapamulin ointment, 1%, for 3 or 5 days. , in Presented at the joint 48th annual interscience conference on antimicrobial agents adn chemotherapy at the 46th Annual Meeting of Infectious Diseases Society of America. 2008: Washington DC.
- Results publication: PubMed 25053981Haddican M, Linkner RV, Singer G, Jim SC, Gagliotti M, Goldenberg G. Retapamulin 1% Ointment and Clobetasol Propionate 0.05% Foam is More Efficacious than Vehicle Ointment and Clobetasol 0.05% Propionate Foam in the Treatment of Hand/Foot Dermatitis: A Single Center, Randomized, Double-blind Study. J Clin Aesthet Dermatol. 2014 Jul;7(7):32-6.
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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.
Gary Goldenberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retapamulin 1% ointment in people with Hand Eczema and Foot Eczema, run by Gary Goldenberg 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 6 inclusion and 9 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 3 Dec 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 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With PGA of 0 or 1 (time frame: Day 15). 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?
On the ClinicalTrials.gov record for NCT01591785, which also lists 12 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 3 Dec 2020.