Lichen Simplex ChronicusNCT06267066
Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus
A study testing Betamethasone Valerate 0.1% Cream, SmartXide® fractional carbon dioxide laser and Vaseline Topical Product in people with Lichen Simplex Chronicus, run by Cairo University at 2 sites in Egypt.
Trial summary
The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Simplex Chronicus
- What is being tested?
- Betamethasone Valerate 0.1% Cream, SmartXide® fractional carbon dioxide laser and Vaseline Topical Product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2024to 30 Aug 2024
- 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
Who may be able to join
- Patients with LSC with no underlying dermatological disease, not on topical or systemic treatment for at least 4 weeks prior to study.
Who cannot join
- Pregnant and lactating females.
- Patients who are diagnosed with any systemic disease that can result in generalized pruritus (e.g. hepatic, renal, uncontrolled diabetes mellitus, thyroid,….etc ) from history.
- Patients with contraindications to laser e.g., keloidal tendency, post inflammatory hyperpigmentation (PIH).
- Patients with dermatological disease (e.g. psoriasis, atopic dermatitis, ….etc)
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Lobna Alieldin
Cairo, 11562
Noha Asem, professor, 01003657120 ext. 20, kasralainirec@yahoo.com
Lobna Alieldin, MSc, 01002279968 ext. 20, Lobnaalieldin@gmail.com
Lobna Alieldin
Cairo, 11562
About this study
Official title: Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus: A Randomized Controlled Trial
The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University.
Participants will:
Read more
- Be assessed clinically by doctor
- Biopsies will be taken from them by doctor
- Receive treatment as laser or topical steroids or both
- Fill in depression questionnaire.
Researchers will divide and compare groups as follows:
Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.
- Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.
- Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.
- Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months. to see if:
- Pruritus severity scale.
- Scaling, erythema, lichenification excoriation scores
- Visual analogue scale.
- Investigator's Global Assessment.
- Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
- Depression improve more in which group of patients after treatment.
Read the detailed description
All the patients were subjected to the following:
- Before treatment:
- Consent: An informed written consent will be signed by each patient before enrolment in the study.
- Detailed history taking :
- Personal history: name, age, sex, skin type, occupation, residence, marital status, and smoking.
- History of present illness: onset, course, duration of disease, precipitating factors and any medications.
- Past history of any associated systemic or dermatological diseases.
- Family history of any dermatological disease e.g. psoriasis, atopic dermatitis,….etc.
- Drug history.
- Skin biopsy: Two 3 mm punch biopsies will be taken from the lesion from each patient under local anesthesia using (Lidocaine®). One for histopathology to confirm diagnosis of LSC and the other for measuring itching mediators in the lesion before treatment by enzyme-linked immunosorbent assay (ELISA)). Another biopsy will be taken from a non lesional skin from same patient for measuring itching mediators by ELISA. Biopsies for ELISA will be stored at -20 degree celsius in eppendorfs with 3 ml phosphate buffer saline (PBS) added to each eppendorf. Tissue samples with PBS will be homogenized by a grinder, then centrifuged for 20 minutes at 3000 revolutions per minute (rpm) speed, the supernatant will be removed to be added to the ELISA kit wells for Human Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
- Clinical assessment:
- Pruritus severity scale.
- Scaling, erythema, lichenification excoriation scores
- Visual analogue scale.
- Investigator's Global Assessment.
- Depression assessment: Beck Depression Inventory questionnaire will be used to assess the depression in each patient .
- Therapeutic Intervention: Patients will be divided as discussed before. - Topical steroids used will be a moderate potency topical steroid.
- Fractional carbon dioxide laser sessions for groups A (1 and 2) by laser machine.
- Parameters of laser session: (Parameters will be adjusted according to skin type, lesion thickness and condition) Power 15 to 20 watt according to skin color. Dwell time 800 to1000 milliseconds. Spacing 600 micrometers. Stack 2 II. After treatment:
- Assessment of biochemical efficacy (measuring itching mediators after treatment): After one month from the last session for group A and after one month from stoppage of steroids for group B, a skin biopsy from the plaque (from a nearby site to the former one) will be taken as discussed before for ELISA.
- Assessment of clinical efficacy by scores as discussed before.
- Depression assessment: Beck Depression Inventory questionnaire will be repeated.
- Assessment of safety:
- Assessment of side effects of laser and their treatment: Erythema, burning sensation, PIH, pruritus and/or pixilation. • Assessment of side effects of topical corticosteroids and their treatment: Atrophy, telangiectasia, hypopigmentation, hypertrichosis, purpura, ulceration, irritation, secondary infection.
- Assessment of side effects of skin biopsy and their treatment: Bleeding, secondary infection and/or Scarring.
- Conditions
- Lichen Simplex Chronicus
- Being tested
- Betamethasone Valerate 0.1% Cream, SmartXide® fractional carbon dioxide laser, Vaseline Topical Product
- Keywords
- Lichen Simplex Chronicus, Fractional carbon dioxide laser, Depression, Interleukin 31, Nerve Growth Factor, Substance P
- Medical subject headings
- Neurodermatitis, Depression, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Valerate 0.1% CreamDrug
Moderate potency
SmartXide® fractional carbon dioxide laserDevice
Ablative
Vaseline Topical ProductDrug
Emollient
| Study group | Role | What they receive |
|---|---|---|
| Topical Corticosteroids | Active comparator | Patients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months. Receives: Drug: Betamethasone Valerate 0.1% Cream; Drug: Vaseline Topical Product |
| Fractional carbon dioxide | Active comparator | Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions. Receives: Device: SmartXide® fractional carbon dioxide laser; Drug: Vaseline Topical Product |
| Combined topical corticosteroids and Laser | Active comparator | Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions. Receives: Drug: Betamethasone Valerate 0.1% Cream; Device: SmartXide® fractional carbon dioxide laser; Drug: Vaseline Topical Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between 2 groups regarding change in Pruritus severity scale
Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
Comparison between 2 groups regarding change in Visual analogue scale
Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
Comparison between 2 groups regarding change in Investigator's Global Assessment.
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
Comparison between 2 groups regarding change in Scaling score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
Comparison between 2 groups regarding change in Erythema score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
Comparison between 2 groups regarding change in Lichenification score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
Comparison between 2 groups regarding change in Excoriation score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
Secondary outcomes (3)
change of depression score in both groups.
Minimum value: 0, Maximum value: 63, higher scores mean a worse outcome.
Measured: through study completion, an average of 5months
change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups
all will be measured by pg/ml
Measured: through study completion, an average of 5months
Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls
all will be measured by pg/ml
Measured: through study completion, an average of 5months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lichen Simplex ChronicusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2) each of 15 patients. All LSC lesions will be treated in any patient having multiple lesions. Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions. Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions. Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Gamal Alieldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267066
- Sponsor's protocol ID
- MD-232-2022
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' data that underlie reported results will be shared upon request, after deidentification, for researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal. This is beginning 3 months up to 12 months after publication.
Publications
Esmat S, Sany I, Alieldin L, Nour Z, Azzazi Y. Fractional Carbon Dioxide Laser for Lichen Simplex Chronicus: A Randomized Controlled Trial. Dermatol Surg. 2026 Mar 1;52(3):247-252. doi: 10.1097/DSS.0000000000004809. Epub 2025 Aug 6.
PubMed 40767880
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06267066
- Acronym / sponsor ID
- MD-232-2022
- Conditions
- Lichen Simplex Chronicus
- Keywords
- Lichen Simplex Chronicus, Fractional carbon dioxide laser, Depression, Interleukin 31, Nerve Growth Factor, Substance P
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University.
Participants will:
- Be assessed clinically by doctor
- Biopsies will be taken from them by doctor
- Receive treatment as laser or topical steroids or both
- Fill in depression questionnaire.
Researchers will divide and compare groups as follows:
Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.
- Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.
- Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.
- Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months. to see if:
- Pruritus severity scale.
- Scaling, erythema, lichenification excoriation scores
- Visual analogue scale.
- Investigator's Global Assessment.
- Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
- Depression improve more in which group of patients after treatment.
Detailed description
All the patients were subjected to the following:
- Before treatment:
- Consent: An informed written consent will be signed by each patient before enrolment in the study.
- Detailed history taking :
- Personal history: name, age, sex, skin type, occupation, residence, marital status, and smoking.
- History of present illness: onset, course, duration of disease, precipitating factors and any medications.
- Past history of any associated systemic or dermatological diseases.
- Family history of any dermatological disease e.g. psoriasis, atopic dermatitis,….etc.
- Drug history.
- Skin biopsy: Two 3 mm punch biopsies will be taken from the lesion from each patient under local anesthesia using (Lidocaine®). One for histopathology to confirm diagnosis of LSC and the other for measuring itching mediators in the lesion before treatment by enzyme-linked immunosorbent assay (ELISA)). Another biopsy will be taken from a non lesional skin from same patient for measuring itching mediators by ELISA. Biopsies for ELISA will be stored at -20 degree celsius in eppendorfs with 3 ml phosphate buffer saline (PBS) added to each eppendorf. Tissue samples with PBS will be homogenized by a grinder, then centrifuged for 20 minutes at 3000 revolutions per minute (rpm) speed, the supernatant will be removed to be added to the ELISA kit wells for Human Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
- Clinical assessment:
- Pruritus severity scale.
- Scaling, erythema, lichenification excoriation scores
- Visual analogue scale.
- Investigator's Global Assessment.
- Depression assessment: Beck Depression Inventory questionnaire will be used to assess the depression in each patient .
- Therapeutic Intervention: Patients will be divided as discussed before. - Topical steroids used will be a moderate potency topical steroid.
- Fractional carbon dioxide laser sessions for groups A (1 and 2) by laser machine.
- Parameters of laser session: (Parameters will be adjusted according to skin type, lesion thickness and condition) Power 15 to 20 watt according to skin color. Dwell time 800 to1000 milliseconds. Spacing 600 micrometers. Stack 2 II. After treatment:
- Assessment of biochemical efficacy (measuring itching mediators after treatment): After one month from the last session for group A and after one month from stoppage of steroids for group B, a skin biopsy from the plaque (from a nearby site to the former one) will be taken as discussed before for ELISA.
- Assessment of clinical efficacy by scores as discussed before.
- Depression assessment: Beck Depression Inventory questionnaire will be repeated.
- Assessment of safety:
- Assessment of side effects of laser and their treatment: Erythema, burning sensation, PIH, pruritus and/or pixilation. • Assessment of side effects of topical corticosteroids and their treatment: Atrophy, telangiectasia, hypopigmentation, hypertrichosis, purpura, ulceration, irritation, secondary infection.
- Assessment of side effects of skin biopsy and their treatment: Bleeding, secondary infection and/or Scarring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2) each of 15 patients. All LSC lesions will be treated in any patient having multiple lesions. Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions. Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions. Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Topical Corticosteroids | Active comparator | Drug: Betamethasone Valerate 0.1% Cream, Drug: Vaseline Topical ProductPatients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months. |
| Fractional carbon dioxide | Active comparator | Device: SmartXide® fractional carbon dioxide laser, Drug: Vaseline Topical ProductPatients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions. |
| Combined topical corticosteroids and Laser | Active comparator | Drug: Betamethasone Valerate 0.1% Cream, Device: SmartXide® fractional carbon dioxide laser, Drug: Vaseline Topical ProductPatients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with LSC with no underlying dermatological disease, not on topical or systemic treatment for at least 4 weeks prior to study.
Key exclusion criteria (4 listed)
- Pregnant and lactating females.
- Patients who are diagnosed with any systemic disease that can result in generalized pruritus (e.g. hepatic, renal, uncontrolled diabetes mellitus, thyroid,….etc ) from history.
- Patients with contraindications to laser e.g., keloidal tendency, post inflammatory hyperpigmentation (PIH).
- Patients with dermatological disease (e.g. psoriasis, atopic dermatitis, ….etc)
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 |
|---|---|---|
| Betamethasone Valerate 0.1% CreamModerate potency | Drug | Combined topical corticosteroids and Laser, Topical Corticosteroids |
| SmartXide® fractional carbon dioxide laserAblative | Device | Combined topical corticosteroids and Laser, Fractional carbon dioxide |
| Vaseline Topical ProductEmollient | Drug | Combined topical corticosteroids and Laser, Fractional carbon dioxide, Topical Corticosteroids |
Primary outcome
Comparison between 2 groups regarding change in Pruritus severity scale
Time frame: through study completion, an average of 5months
Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Visual analogue scale
Time frame: through study completion, an average of 5months
Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Investigator's Global Assessment.
Time frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Scaling score
Time frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Erythema score
Time frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Lichenification score
Time frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Excoriation score
Time frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
3 secondary outcomes
change of depression score in both groups.
Time frame: through study completion, an average of 5months
change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups
Time frame: through study completion, an average of 5months
Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls
Time frame: through study completion, an average of 5months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40767880Esmat S, Sany I, Alieldin L, Nour Z, Azzazi Y. Fractional Carbon Dioxide Laser for Lichen Simplex Chronicus: A Randomized Controlled Trial. Dermatol Surg. 2026 Mar 1;52(3):247-252. doi: 10.1097/DSS.0000000000004809. Epub 2025 Aug 6.
- Individual participant dataSharing planned: Yes. Participants' data that underlie reported results will be shared upon request, after deidentification, for researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal. This is beginning 3 months up to 12 months after publication.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone Valerate 0.1% Cream, SmartXide® fractional carbon dioxide laser and Vaseline Topical Product in people with Lichen Simplex Chronicus, run by Cairo University at 2 sites in Egypt.
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 1 inclusion and 4 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between 2 groups regarding change in Pruritus severity scale (time frame: through study completion, an average of 5months). The study lists 7 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 NCT06267066, which also lists 1 linked publication.
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 20 Feb 2024.