Striae; AlbicantesNCT04165226

LLLT and Fractional CO2 Laser in the Treatment of Stria Alba

A study testing Low level light therapy, Fractional CO2 and Combined fractional CO2 laser and low level light therapy in people with Striae; Albicantes, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Stria alba (aka white or atrophic stretch marks) is a very common dermatologic condition that causes major psychological distress to those afflicted. We study the effect of low level light therapy using infra red diode 808/915 nm laser in comparison to fractional CO2 alone and combined both therapies. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Striae; Albicantes
What is being tested?: Low level light therapy, Fractional CO2 and Combined fractional CO2 laser and low level light therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 24 Nov 2018to 17 Sep 2019
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

Subjects, above the age of 18 years old, with stria alba.
Both genders.

Who cannot join

Pregnant or lactating females.
Subjects who were treated with any interventional procedure (lasers, radiofrequency, dermabrasion, microdermabrasion, or chemical peeling) within 6 months prior to the study.
Subjects who applied topical corticosteroids, retinoid, vitamin C, or vitamin E within 3 months prior to the study.
Subjects who orally took retinoids or corticosteroids within 3 months.
Subjects who had a history of hypertrophic scar, keloid or immunosuppression or cancer.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Kasr El Ainy hospital
Cairo

Other trials in Egypt

About this study

Official title: Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study

Read the detailed description

All patients will be subjected to the following:

Written informed consent.
Detailed history and clinical evaluation.

The treated areas will be photographed (in standardized settings of light and position) and measured in order to allow comparison and assessment of striae improvement following treatment.

Patients will be allocated according to randomization into one of 3 arms:

Arm A will be treated by fractional CO2 laser. Arm B will be treated by low level light therapy (LLLT). Arm C will be treated with a combination of fractional CO2 laser and LLLT.

Digital photographs will be taken for each patient, at the baseline and 1 and 3 months after last session and the width of the widest striae in each patient will be measured at the same time. Patients will be assessed before and after treatment by one unblinded and 2 blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).

In addition, a patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire (Yang and Lee; 2011).

Conditions: Striae; Albicantes
Being tested: Low level light therapy, Fractional CO2, Combined fractional CO2 laser and low level light therapy
Keywords: Stria alba, Fractional CO2, Fractional carbon dioxide laser 00, Low level light therapy, Striae atrophicae, Infra red diode laser, 808 nm, 915 nm, 10600 nm
Medical subject headings: Striae Distensae

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low level light therapyDevice
Patients will be offered 8 sessions of photobiomodulation using HPL Pagani Diode 808/915nm LLLT 3.2W (Fimad Elettromedicali SRL®, Catanzaro, Italy) with the parameters adjusted individually according to the surface area to be treated. Optimum dose is 10 joules/cubic centimeters. The patients will take 2 to3 sessions / week.
Fractional CO2Device
Patients will be offered 2 sessions of fractional carbon dioxide laser on a 4 weeks interval. Topical anesthesia with pridocaine cream will be applied under occlusion for 30 - 60 minutes before the session.
- Please update to the proper apparatus and parameters DEXA SmartXide DOT Fractional CO2 laser system 10600 nm (DEKA®, Florence, Italy) will be used with the following parameters adjusted individually to patients': power of 15-20 W, dwell time of 500-800 μs, spacing of 200-500 μm, and stack 2.
Combined fractional CO2 laser and low level light therapyDevice
Combined treatment of both modalities (fractionational CO2 laser and low level light therapy). Please describe more....

Study groups in NCT04165226
Study group	Role	What they receive
Low level light therapy (LLLT)	Active comparator	Low level light therapy using 808/915 nm infra red diode laser Receives: Device: Low level light therapy
Fractional CO2	Active comparator	Fractional carbon dioxide laser 10600 nm Receives: Device: Fractional CO2
Combined fractional CO2 and LLLT	Active comparator	Combined fractional CO2 laser and low level light therapy Receives: Device: Combined fractional CO2 laser and low level light therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).
Measured: 3 months
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study)
Patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire
Measured: 3 months
Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study)
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).
Measured: 3 months

Secondary outcomes (5)

Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).
Measured: 1 month
Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).
Measured: 1 month
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1
Patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire
Measured: 1 month
Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling)
Percentage of incidence of side effects (edema, pain, erythema, itching, start of peeling) in all patients
Measured: 3 months
Comparative tolerability of the fractional CO2 versus combined fractional and LLLT as regards duration of side effects in days after each laser session (edema, pain, erythema, itching, peeling)
Comparative tolerability of the fractional CO2 versus combined fractional and LLLT as regards duration of side effects in days after each laser session (edema, pain, erythema, itching, peeling)
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 201817 Sep 2019

First posted15 Nov 2019
Study start24 Nov 2018
Primary completion17 Sep 2019
Study completion17 Sep 2019

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 Striae; AlbicantesStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04165226
Sponsor's protocol ID: MMikhail
Status last verified: Jun 2020
First submitted: 20 Dec 2018
Last updated: 17 Jun 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD that underlie results in a publication, as well as protocol and statistical plan analysis, are to be published starting 6 months after the publication of summary data.

Publications

Yang YJ, Lee GY. Treatment of Striae Distensae with Nonablative Fractional Laser versus Ablative CO(2) Fractional Laser: A Randomized Controlled Trial. Ann Dermatol. 2011 Nov;23(4):481-9. doi: 10.5021/ad.2011.23.4.481. Epub 2011 Nov 3.
PubMed 22148016
Weiss RA, McDaniel DH, Geronemus RG, Weiss MA, Beasley KL, Munavalli GM, Bellew SG. Clinical experience with light-emitting diode (LED) photomodulation. Dermatol Surg. 2005 Sep;31(9 Pt 2):1199-205. doi: 10.1111/j.1524-4725.2005.31926.
PubMed 16176771
Hamblin, M. R. (2017, May 19). Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/28748217/
Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.
PubMed 25653800
Anders, J. J., Lanzafame, R. J., & Arany, P. R. (2015, April 01). Clinical features and risk factors for striae distensae in Korean adolescents. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4390214/
K. Sawhney, Mossum & Hamblin, Michael. (2014). Low-level light therapy (LLLT) for cosmetics and dermatology. Progress in Biomedical Optics and Imaging - Proceedings of SPIE. 8932. 10.1117/12.2041330.
Aldahan AS, Shah VV, Mlacker S, Samarkandy S, Alsaidan M, Nouri K. Laser and Light Treatments for Striae Distensae: A Comprehensive Review of the Literature. Am J Clin Dermatol. 2016 Jun;17(3):239-56. doi: 10.1007/s40257-016-0182-8.
PubMed 26923916
Ross NA, Ho D, Fisher J, Mamalis A, Heilman E, Saedi N, Jagdeo J. Striae Distensae: Preventative and Therapeutic Modalities to Improve Aesthetic Appearance. Dermatol Surg. 2017 May;43(5):635-648. doi: 10.1097/DSS.0000000000001079.
PubMed 28375972
Mishra V, Miller L, Alsaad SM, Ross EV. The Use of a Fractional Ablative Micro-Plasma Radiofrequency Device in Treatment of Striae. J Drugs Dermatol. 2015 Nov;14(11):1205-8.
PubMed 26580868
Ibrahim ZA, El-Tatawy RA, El-Samongy MA, Ali DA. Comparison between the efficacy and safety of platelet-rich plasma vs. microdermabrasion in the treatment of striae distensae: clinical and histopathological study. J Cosmet Dermatol. 2015 Dec;14(4):336-46. doi: 10.1111/jocd.12160. Epub 2015 Jul 6.
PubMed 26147455
Mazzarello V, Farace F, Ena P, Fenu G, Mulas P, Piu L, Rubino C. A superficial texture analysis of 70% glycolic acid topical therapy and striae distensae. Plast Reconstr Surg. 2012 Mar;129(3):589e-590e. doi: 10.1097/PRS.0b013e3182419c40. No abstract available.
PubMed 22374035
Ud-Din S, McAnelly SL, Bowring A, Whiteside S, Morris J, Chaudhry I, Bayat A. A double-blind controlled clinical trial assessing the effect of topical gels on striae distensae (stretch marks): a non-invasive imaging, morphological and immunohistochemical study. Arch Dermatol Res. 2013 Sep;305(7):603-17. doi: 10.1007/s00403-013-1336-7. Epub 2013 Apr 12.
PubMed 23579949
Elson, M. (1994). Topical tretinoin in the treatment of striae distensae and in the promotion of wound healing: A review. Journal of Dermatological Treatment, 5(3), 163-165. doi:10.3109/09546639409084563
Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x.
PubMed 9747352
Lee KS, Rho YJ, Jang SI, Suh MH, Song JY. Decreased expression of collagen and fibronectin genes in striae distensae tissue. Clin Exp Dermatol. 1994 Jul;19(4):285-8. doi: 10.1111/j.1365-2230.1994.tb01196.x.
PubMed 7955466

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study
ClinicalTrials.gov ID: NCT04165226
Acronym / sponsor ID: MMikhail
Conditions: Striae; Albicantes
Keywords: Stria alba, Fractional CO2, Fractional carbon dioxide laser 00, Low level light therapy, Striae atrophicae, Infra red diode laser, 808 nm, 915 nm
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Kasr El Aini HospitalUniversity, hospital or other
Study start: 24 Nov 2018 (actual)
Primary completion: 17 Sep 2019 (actual)
Study completion: 17 Sep 2019 (actual)
First posted: 15 Nov 2019 (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.

Detailed description

All patients will be subjected to the following:

Written informed consent.
Detailed history and clinical evaluation.

The treated areas will be photographed (in standardized settings of light and position) and measured in order to allow comparison and assessment of striae improvement following treatment.

Patients will be allocated according to randomization into one of 3 arms:

Arm A will be treated by fractional CO2 laser. Arm B will be treated by low level light therapy (LLLT). Arm C will be treated with a combination of fractional CO2 laser and LLLT.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low level light therapy (LLLT)	Active comparator	Device: Low level light therapyLow level light therapy using 808/915 nm infra red diode laser
Fractional CO2	Active comparator	Device: Fractional CO2Fractional carbon dioxide laser 10600 nm
Combined fractional CO2 and LLLT	Active comparator	Device: Combined fractional CO2 laser and low level light therapyCombined fractional CO2 laser and low level light therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects, above the age of 18 years old, with stria alba.
Both genders.

Key exclusion criteria (5 listed)

Pregnant or lactating females.
Subjects who were treated with any interventional procedure (lasers, radiofrequency, dermabrasion, microdermabrasion, or chemical peeling) within 6 months prior to the study.
Subjects who applied topical corticosteroids, retinoid, vitamin C, or vitamin E within 3 months prior to the study.
Subjects who orally took retinoids or corticosteroids within 3 months.
Subjects who had a history of hypertrophic scar, keloid or immunosuppression or cancer.

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
Low level light therapyPatients will be offered 8 sessions of photobiomodulation using HPL Pagani Diode 808/915nm LLLT 3.2W (Fimad Elettromedicali SRL®, Catanzaro, Italy) with the parameters adjusted individually according to the surface area to be treated. Optimum dose is 10 joules/cubic centimeters. The patients will take 2 to3 sessions / week.	Device	Low level light therapy (LLLT)
Fractional CO2Patients will be offered 2 sessions of fractional carbon dioxide laser on a 4 weeks interval. Topical anesthesia with pridocaine cream will be applied under occlusion for 30 - 60 minutes before the session. * Please update to the proper apparatus and parameters DEXA SmartXide DOT Fractional CO2 laser system 10600 nm (DEKA®, Florence, Italy) will be used with the following parameters adjusted individually to patients': power of 15-20 W, dwell time of 500-800 μs, spacing of 200-500 μm, and stack 2.	Device	Fractional CO2
Combined fractional CO2 laser and low level light therapyCombined treatment of both modalities (fractionational CO2 laser and low level light therapy). Please describe more....	Device	Combined fractional CO2 and LLLT

Primary outcome

Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)
Time frame: 3 months
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study)
Time frame: 3 months
Patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire
Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study)
Time frame: 3 months
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).

5 secondary outcomes

Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1
Time frame: 1 month
Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1
Time frame: 1 month
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1
Time frame: 1 month
Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling)
Time frame: 3 months
Comparative tolerability of the fractional CO2 versus combined fractional and LLLT as regards duration of side effects in days after each laser session (edema, pain, erythema, itching, peeling)
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Background: PubMed 22148016Yang YJ, Lee GY. Treatment of Striae Distensae with Nonablative Fractional Laser versus Ablative CO(2) Fractional Laser: A Randomized Controlled Trial. Ann Dermatol. 2011 Nov;23(4):481-9. doi: 10.5021/ad.2011.23.4.481. Epub 2011 Nov 3.
Background: PubMed 16176771Weiss RA, McDaniel DH, Geronemus RG, Weiss MA, Beasley KL, Munavalli GM, Bellew SG. Clinical experience with light-emitting diode (LED) photomodulation. Dermatol Surg. 2005 Sep;31(9 Pt 2):1199-205. doi: 10.1111/j.1524-4725.2005.31926.
BackgroundHamblin, M. R. (2017, May 19). Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/28748217/
Background: PubMed 25653800Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.
BackgroundAnders, J. J., Lanzafame, R. J., & Arany, P. R. (2015, April 01). Clinical features and risk factors for striae distensae in Korean adolescents. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4390214/
BackgroundK. Sawhney, Mossum & Hamblin, Michael. (2014). Low-level light therapy (LLLT) for cosmetics and dermatology. Progress in Biomedical Optics and Imaging - Proceedings of SPIE. 8932. 10.1117/12.2041330.
Background: PubMed 26923916Aldahan AS, Shah VV, Mlacker S, Samarkandy S, Alsaidan M, Nouri K. Laser and Light Treatments for Striae Distensae: A Comprehensive Review of the Literature. Am J Clin Dermatol. 2016 Jun;17(3):239-56. doi: 10.1007/s40257-016-0182-8.
Background: PubMed 28375972Ross NA, Ho D, Fisher J, Mamalis A, Heilman E, Saedi N, Jagdeo J. Striae Distensae: Preventative and Therapeutic Modalities to Improve Aesthetic Appearance. Dermatol Surg. 2017 May;43(5):635-648. doi: 10.1097/DSS.0000000000001079.
Background: PubMed 26580868Mishra V, Miller L, Alsaad SM, Ross EV. The Use of a Fractional Ablative Micro-Plasma Radiofrequency Device in Treatment of Striae. J Drugs Dermatol. 2015 Nov;14(11):1205-8.
Background: PubMed 26147455Ibrahim ZA, El-Tatawy RA, El-Samongy MA, Ali DA. Comparison between the efficacy and safety of platelet-rich plasma vs. microdermabrasion in the treatment of striae distensae: clinical and histopathological study. J Cosmet Dermatol. 2015 Dec;14(4):336-46. doi: 10.1111/jocd.12160. Epub 2015 Jul 6.
Background: PubMed 22374035Mazzarello V, Farace F, Ena P, Fenu G, Mulas P, Piu L, Rubino C. A superficial texture analysis of 70% glycolic acid topical therapy and striae distensae. Plast Reconstr Surg. 2012 Mar;129(3):589e-590e. doi: 10.1097/PRS.0b013e3182419c40. No abstract available.
Background: PubMed 23579949Ud-Din S, McAnelly SL, Bowring A, Whiteside S, Morris J, Chaudhry I, Bayat A. A double-blind controlled clinical trial assessing the effect of topical gels on striae distensae (stretch marks): a non-invasive imaging, morphological and immunohistochemical study. Arch Dermatol Res. 2013 Sep;305(7):603-17. doi: 10.1007/s00403-013-1336-7. Epub 2013 Apr 12.
Low level light therapy deviceLink provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD that underlie results in a publication, as well as protocol and statistical plan analysis, are to be published starting 6 months after the publication of summary data.

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.

Doaa Mahgoub, MD principal investigator

Cairo University

Vanessa Hafez, MD principal investigator

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 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 17 Jun 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study) (time frame: 3 months). The study lists 3 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 NCT04165226, 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 17 Jun 2020.