Atrophic Acne ScarNCT05105334
Combined Therapy for Acne Scars
A study testing Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone and Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) in people with Atrophic Acne Scar, run by Goldman, Butterwick, Fitzpatrick and Groff.
Trial summary
Compare the effectiveness of nonablative fractional resurfacing to radiofrequency micrnoeedling for facial acne scars in all skin types Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone and Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2021to 8 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
- Inclusion criteria
- Male or female in general good health ages 18 and older
- Fitzpatrick skin type I-VI
- Subject has completed an appropriately administered informed consent process which includes signing the IRB approved consent form
- Negative urine pregnancy test at baseline (if applicable)
- Willingness to have facial exams and digital photos performed of the face
- Moderate to severe atrophic acne scarring on the face per ECCA (échelle d'évaluation clinique des cicatrices d'acné) acne grading scale
- No change in estrogen releasing contraceptive method in 3 months, and no plans to change this contraceptive method during the course of the study
- No change in topical skin care
- Female patients will be either of non-childbearing potential defined as:
- Having no uterus
- No menses for at least 12 months. Or; Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study, such as: <!-- -->
- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- Intrauterine coil
- Bilateral tubal ligation
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized).
- Exclusion criteria
- Presence of incompletely healed wound in treatment area
- Pregnant, planning pregnancy or breastfeeding during the course of the study
- Energy-based device treatment in the treatment area in the last 6 months
- Treatments with a dermal filler or biostimulatory agent in the treatment area within the past 12 months
- Recent use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide or diclofenac to the face within the previous 2 weeks.
- Individuals who have had a chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study
- Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) or the presence of suspected BCC or SCC in treatment area at investigator's discretion
- Has skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area
- Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below)
- Individuals with active psoriasis, eczema, sunburn, excessive scarring, tattoos, or other skin condition on the face that would interfere with the assessments of this study
- Subjects who participated on another study within the last 30 days
- Subjects currently on or planning to participate in any type of research study at another facility or a doctor's office during this study
- Subjects with a predisposition to keloid formation following surgery
- Subjects on systemic steroids (e.g. prednisone, dexamethasone), or topical steroids on the face which should be rigorously avoided prior to and throughout the course of treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Combined Treatment With Nonablative Fractional Laser and Radiofrequency Microneedling for the Treatment of Acne Scars: A Prospective, Randomized, Split-Face Study
Compare the effectiveness of nonablative fractional resurfacing to radiofrequency micrnoeedling for facial acne scars in all skin types
Read the detailed description
Quantify and compare the effectiveness of nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone to nonablative fractional laser alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) for the treatment of atrophic, facial acne scars in all skin types.
- Conditions
- Atrophic Acne Scar
- Being tested
- Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone, Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA)
- Keywords
- Acne, Acne scar, Face, Microneedling, Intracel, Fraxel
- Medical subject headings
- Acne Vulgaris, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) aloneDevice
Nonablative fractional 1550 nm erbium:glass laser. Settings: 40-70 mJ, treatment level 5-7 (14-20% coverage), 8 passes with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. To be repeated for a total of 4 sessions at 4-week intervals.
Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA)Device
Nonablative fractional 1550 nm erbium:glass laser. Settings: 40-70 mJ, treatment level 5-7 (14-20% coverage), 8 passes with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. This will be alternated with radiofrequency microneedling treatment will include 3 passes each at a depth of 2 mm, 1.5 mm, and 0.8 mm, treatment level 5 (32 w, 50 ms)-7 (40 w, 60 ms), monopolar setting with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. To be repeated for a total of 4 sessions (2 of each modality) at 4-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Nonablative fractional laser alone | Experimental | Not described Receives: Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone |
| Nonablative fractional laser alternating with microneedling with radiofrequency | Experimental | Not described Receives: Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone; Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in atrophic acne scar
The primary study endpoint will be clinical efficacy defined as change in atrophic acne scarring based on the ECCA grading scale and a 1-10 percentile scale.
Measured: 3 months after final treatment
Secondary outcomes (4)
Subject comfort level
During each treatment visit patients will be asked to grade pain of treatment on a pain visual analog scale.
Measured: To be done right after treatments
Subjective change
Subjects will rate their perceived global change in acne scarring based on the subjected assessed global improvement scale.
Measured: 3 months after final treatment
Subject satisfaction
Subjects will rate satisfaction on a 1-5 scale.
Measured: 3 months after final treatment
Adverse events
To be recorded by treating physician after treatment.
Measured: 3 months after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start8 Nov 2021 (estimated)
- Primary completion8 May 2022 (estimated)
- Study completion8 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarStudies 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
- Prospective, randomized, split-face, evaluator-blinded study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Semsarzadeh, MD, Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105334
- Sponsor's protocol ID
- Fraxel/Intracel-2021-8
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tan J, Kang S, Leyden J. Prevalence and Risk Factors of Acne Scarring Among Patients Consulting Dermatologists in the USA. J Drugs Dermatol. 2017 Feb 1;16(2):97-102.
PubMed 28300850Boen M, Jacob C. A Review and Update of Treatment Options Using the Acne Scar Classification System. Dermatol Surg. 2019 Mar;45(3):411-422. doi: 10.1097/DSS.0000000000001765.
PubMed 30856634Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
PubMed 15216537Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg. 2007 Mar;33(3):295-9. doi: 10.1111/j.1524-4725.2007.33059.x.
PubMed 17338686Hu S, Chen MC, Lee MC, Yang LC, Keoprasom N. Fractional resurfacing for the treatment of atrophic facial acne scars in asian skin. Dermatol Surg. 2009 May;35(5):826-32. doi: 10.1111/j.1524-4725.2009.01139.x. Epub 2009 Apr 6.
PubMed 19397671Hedelund L, Moreau KE, Beyer DM, Nymann P, Haedersdal M. Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation. Lasers Med Sci. 2010 Sep;25(5):749-54. doi: 10.1007/s10103-010-0801-1. Epub 2010 Jun 17.
PubMed 20556471Bencini PL, Tourlaki A, Galimberti M, Longo C, Pellacani G, De Giorgi V, Guerriero G. Nonablative fractional photothermolysis for acne scars: clinical and in vivo microscopic documentation of treatment efficacy. Dermatol Ther. 2012 Sep-Oct;25(5):463-7. doi: 10.1111/j.1529-8019.2012.01478.x.
PubMed 23046026Al-Dhalimi M, Jaber A. Treatment of atrophic facial acne scars with fractional Er:Yag laser. J Cosmet Laser Ther. 2015;17(4):184-8. doi: 10.3109/14764172.2015.1007067. Epub 2015 Feb 13.
PubMed 25588037Alexis AF, Coley MK, Nijhawan RI, Luke JD, Shah SK, Argobi YA, Nodzenski M, Veledar E, Alam M. Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI. Dermatol Surg. 2016 Mar;42(3):392-402. doi: 10.1097/DSS.0000000000000640.
PubMed 26945321Gold MH, Biron JA. Treatment of acne scars by fractional bipolar radiofrequency energy. J Cosmet Laser Ther. 2012 Aug;14(4):172-8. doi: 10.3109/14764172.2012.687824. Epub 2012 May 30.
PubMed 22548644Cho SI, Chung BY, Choi MG, Baek JH, Cho HJ, Park CW, Lee CH, Kim HO. Evaluation of the clinical efficacy of fractional radiofrequency microneedle treatment in acne scars and large facial pores. Dermatol Surg. 2012 Jul;38(7 Pt 1):1017-24. doi: 10.1111/j.1524-4725.2012.02402.x. Epub 2012 Apr 9.
PubMed 22487513Chandrashekar BS, Sriram R, Mysore R, Bhaskar S, Shetty A. Evaluation of microneedling fractional radiofrequency device for treatment of acne scars. J Cutan Aesthet Surg. 2014 Apr;7(2):93-7. doi: 10.4103/0974-2077.138328.
PubMed 25136209Vejjabhinanta V, Wanitphakdeedecha R, Limtanyakul P, Manuskiatti W. The efficacy in treatment of facial atrophic acne scars in Asians with a fractional radiofrequency microneedle system. J Eur Acad Dermatol Venereol. 2014 Sep;28(9):1219-25. doi: 10.1111/jdv.12267. Epub 2013 Sep 24.
PubMed 25158223Kaminaka C, Uede M, Matsunaka H, Furukawa F, Yamamoto Y. Clinical studies of the treatment of facial atrophic acne scars and acne with a bipolar fractional radiofrequency system. J Dermatol. 2015 Jun;42(6):580-7. doi: 10.1111/1346-8138.12864. Epub 2015 Apr 9.
PubMed 25855397Bulbul Baskan E, Akin Belli A. Evaluation of the efficacy of microneedle fractional radiofrequency in Turkish patients with atrophic facial acne scars. J Cosmet Dermatol. 2019 Oct;18(5):1317-1321. doi: 10.1111/jocd.12812. Epub 2018 Nov 11.
PubMed 30417509
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Treatment With Nonablative Fractional Laser and Radiofrequency Microneedling for the Treatment of Acne Scars: A Prospective, Randomized, Split-Face Study
- ClinicalTrials.gov ID
- NCT05105334
- Acronym / sponsor ID
- Fraxel/Intracel-2021-8
- Conditions
- Atrophic Acne Scar
- Keywords
- Acne, Acne scar, Face, Microneedling, Intracel, Fraxel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 8 Nov 2021 (estimated)
- Primary completion
- 8 May 2022 (estimated)
- Study completion
- 8 Jul 2022 (estimated)
- First posted
- 3 Nov 2021 (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.
Compare the effectiveness of nonablative fractional resurfacing to radiofrequency micrnoeedling for facial acne scars in all skin types
Detailed description
Quantify and compare the effectiveness of nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone to nonablative fractional laser alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) for the treatment of atrophic, facial acne scars in all skin types.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, split-face, evaluator-blinded study
| Arm | Type | Receives |
|---|---|---|
| Nonablative fractional laser alone | Experimental | Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone |
| Nonablative fractional laser alternating with microneedling with radiofrequency | Experimental | Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone, Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) aloneNonablative fractional 1550 nm erbium:glass laser. Settings: 40-70 mJ, treatment level 5-7 (14-20% coverage), 8 passes with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. To be repeated for a total of 4 sessions at 4-week intervals. | Device | Nonablative fractional laser alone, Nonablative fractional laser alternating with microneedling with radiofrequency |
| Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA)Nonablative fractional 1550 nm erbium:glass laser. Settings: 40-70 mJ, treatment level 5-7 (14-20% coverage), 8 passes with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. This will be alternated with radiofrequency microneedling treatment will include 3 passes each at a depth of 2 mm, 1.5 mm, and 0.8 mm, treatment level 5 (32 w, 50 ms)-7 (40 w, 60 ms), monopolar setting with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. To be repeated for a total of 4 sessions (2 of each modality) at 4-week intervals. | Device | Nonablative fractional laser alternating with microneedling with radiofrequency |
Primary outcome
Change in atrophic acne scar
Time frame: 3 months after final treatment
The primary study endpoint will be clinical efficacy defined as change in atrophic acne scarring based on the ECCA grading scale and a 1-10 percentile scale.
4 secondary outcomes
Subject comfort level
Time frame: To be done right after treatments
Subjective change
Time frame: 3 months after final treatment
Subject satisfaction
Time frame: 3 months after final treatment
Adverse events
Time frame: 3 months after final treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 28300850Tan J, Kang S, Leyden J. Prevalence and Risk Factors of Acne Scarring Among Patients Consulting Dermatologists in the USA. J Drugs Dermatol. 2017 Feb 1;16(2):97-102.
- Background: PubMed 30856634Boen M, Jacob C. A Review and Update of Treatment Options Using the Acne Scar Classification System. Dermatol Surg. 2019 Mar;45(3):411-422. doi: 10.1097/DSS.0000000000001765.
- Background: PubMed 15216537Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
- Background: PubMed 17338686Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg. 2007 Mar;33(3):295-9. doi: 10.1111/j.1524-4725.2007.33059.x.
- Background: PubMed 19397671Hu S, Chen MC, Lee MC, Yang LC, Keoprasom N. Fractional resurfacing for the treatment of atrophic facial acne scars in asian skin. Dermatol Surg. 2009 May;35(5):826-32. doi: 10.1111/j.1524-4725.2009.01139.x. Epub 2009 Apr 6.
- Background: PubMed 20556471Hedelund L, Moreau KE, Beyer DM, Nymann P, Haedersdal M. Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation. Lasers Med Sci. 2010 Sep;25(5):749-54. doi: 10.1007/s10103-010-0801-1. Epub 2010 Jun 17.
- Background: PubMed 23046026Bencini PL, Tourlaki A, Galimberti M, Longo C, Pellacani G, De Giorgi V, Guerriero G. Nonablative fractional photothermolysis for acne scars: clinical and in vivo microscopic documentation of treatment efficacy. Dermatol Ther. 2012 Sep-Oct;25(5):463-7. doi: 10.1111/j.1529-8019.2012.01478.x.
- Background: PubMed 25588037Al-Dhalimi M, Jaber A. Treatment of atrophic facial acne scars with fractional Er:Yag laser. J Cosmet Laser Ther. 2015;17(4):184-8. doi: 10.3109/14764172.2015.1007067. Epub 2015 Feb 13.
- Background: PubMed 26945321Alexis AF, Coley MK, Nijhawan RI, Luke JD, Shah SK, Argobi YA, Nodzenski M, Veledar E, Alam M. Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI. Dermatol Surg. 2016 Mar;42(3):392-402. doi: 10.1097/DSS.0000000000000640.
- Background: PubMed 22548644Gold MH, Biron JA. Treatment of acne scars by fractional bipolar radiofrequency energy. J Cosmet Laser Ther. 2012 Aug;14(4):172-8. doi: 10.3109/14764172.2012.687824. Epub 2012 May 30.
- Background: PubMed 22487513Cho SI, Chung BY, Choi MG, Baek JH, Cho HJ, Park CW, Lee CH, Kim HO. Evaluation of the clinical efficacy of fractional radiofrequency microneedle treatment in acne scars and large facial pores. Dermatol Surg. 2012 Jul;38(7 Pt 1):1017-24. doi: 10.1111/j.1524-4725.2012.02402.x. Epub 2012 Apr 9.
- Background: PubMed 25136209Chandrashekar BS, Sriram R, Mysore R, Bhaskar S, Shetty A. Evaluation of microneedling fractional radiofrequency device for treatment of acne scars. J Cutan Aesthet Surg. 2014 Apr;7(2):93-7. doi: 10.4103/0974-2077.138328.
- 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.
Nina Semsarzadeh, MD principal investigator
Cosmetic Laser Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone and Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) in people with Atrophic Acne Scar, run by Goldman, Butterwick, Fitzpatrick and Groff.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Sherif Mikhail, MD (8586571004, research@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in atrophic acne scar (time frame: 3 months after final treatment). 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 NCT05105334, which also lists 20 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 10 Nov 2021.