Acne VulgarisPhase 2NCT04870489
Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars
A Phase 2 study testing Isotretinoin and CO2 laser and Co2 laser in people with Acne Vulgaris, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Isotretinoin is an FDA-approved vitamin A metabolite for the treatment of severe acne; acne that does not respond to other treatments and has a tendency to cause scarring. Ablative laser treatment is another effective treatment against acne scarring. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Isotretinoin and CO2 laser and Co2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 1 Jun 2022
- Phase
- Phase 2
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy individuals
- Age 15-60 years old
- Male/Female
- Acne moderate to severe with scarring
- Finished at least 2 months of treatment with Isotretinoin
Who cannot join
- Prior laser treatment for acne scarring
- Patients that have a tendency to have abnormal scarring
- Patients that are immunosuppressed or patients receiving immunosuppressive treatment
- Prior radiotherapy treatment to affected area
- Infected acne
- Rosacea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional Ablative CO2 Laser Treatment for Acne Scars in Patients Receiving Oral Isotretinoin
Isotretinoin is an FDA-approved vitamin A metabolite for the treatment of severe acne; acne that does not respond to other treatments and has a tendency to cause scarring.
Ablative laser treatment is another effective treatment against acne scarring. We believe that the combination of CO2 ablative laser treatment with oral isotretinoin for the treatment of scarring is not only safer but also more effective and leads to much more successful cosmetic results.
Read the detailed description
Patients treated with Isotretinoin for at least 2 months with doses ranging from 20 mg-40 mg per day were treated with Co2 ablative laser on one side of the face (randomized). Patients will be treated with a single session using the fractional AcuPulse CO2 laser (AcuPulse; Lumenis Inc., Santa Clara, CA), with the AcuScan120™ scanner hand-piece and the Deep FX mode. The treatment areas will be cleansed with a mild cleanser and 70% alcohol. Local anesthesia, comprising a topical eutectic mixture of 2.5% lidocaine hydrochloric acid and 2.5% prilocaine cream (EMLA Cream; Astra Zeneca AB, Sweden), will be applied to the treated side of the face under occlusion before laser therapy. After an hour of application, the anesthetic cream will gently be removed, and then, to obtain a completely dry skin surface.Treatment parameters will be a flounce of 15 mj and density of 15% in single-pass treatment without overlapping pulse. Immediately after the treatment, gauzes moistened with cold saline solution must be gently applied (without rubbing) on the skin for 15-20 minutes. Thereafter a thin layer of mupirocin 2% ointment (TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL) will be applied on the skin.
After the procedure, a visual analog scale (VAS) will be used to determine the amount of pain felt by the participants. No pain will be scored as 0, and intolerable pain will be scored as 10 in this scale. Photographs will be taken at baseline; before each treatment; and 6 months after the last treatment. Acne scars will be graded by using the Quantitative Global Acne Scarring Grading System, which takes into account the quantity and type of scar based on a point system (13). With this grading scale, the total score can vary from 0 to 84. The overall score will be determined as the "acne scar score". All assessments will be done by two independent physicians and the mean value of the two assessments will be calculated. A 25% or less decrease in the acne scar score was defined as "mild improvement", 26-50% decrease as "moderate improvement", 51-75% decrease as "significant improvement", and over 75% as "near total improvement". Lack of decrease in the acne scar score was defined as "no change" and an increase in the score was defined as "worsening".
Subjective self-assessment by the participants were done 6 months after the last treatment and was scored as follows: - 1 as "worsening", 0 as "no change", 1 as "mild improvement", 2 as "moderate improvement", 3 as "significant improvement ", and 4 as "near total improvement". At this point, all patients will be 6 months after cessation of oral isotretinoin and will be treated with CO2 laser to the second half of the face with the same treatment parameters All patients will receive CO2 laser treatment once a month for 3 consecutive months (LASER treatment will be identical to the treatment mentioned above for the first half of the face).
The LASER treatment for the second half of the face will be also evaluated by two independent physicians and will be compared to the first side of the face which was previously treated. Both physicians will not be aware as to which side of the face is treated with laser during oral intake of isotretinoin and which side is not.
- Conditions
- Acne Vulgaris
- Being tested
- Isotretinoin and CO2 laser, Co2 laser
- Keywords
- acne vulgaris;scars; CO2 laser; ISOTRETINOIN;treatments
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotretinoin and CO2 laserCombination product
Patients must complete at least 2 months of Isotretinoin prior to starting the study and then continue it for the duration of the 3 months of treatment with the CO2 laser.
Co2 laserDevice
After 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin + Co2 ablative laser | Active comparator | Isotretinoin treatment while being treated with CO2 laser Receives: Combination Product: Isotretinoin and CO2 laser |
| Co2 ablative laser | Active comparator | 6 months to 1 year without isotretinoin treatments to start second side of face with CO2 ablative laser only Receives: Device: Co2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Global Acne Scarring Grading System
With this acne scars grading scale, the total score can vary from 0 to 84. The overall score will be determined as the "acne scar score". A 25% or less decrease in the acne scar score was defined as "mild improvement", 26-50% decrease as "moderate improvement", 51-75% decrease as "significant improvement", and over 75% as "near total improvement"
Measured: Photographs taken at baseline; before each treatment; and 6 months after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Nov 2017
- Primary completion30 Nov 2020
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients are treated with Isotretinoin for at least 2 months prior to starting Co2 laser treatment, then they receive laser treatment on one side of the face (randomized) while still taking Isotretinoin; 6 months after cessation of Isotretinoin or any other treatment they are then treated with Co2 laser only on the second side of the face
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eli Sprecher, Professor, Study chair, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870489
- Sponsor's protocol ID
- 0629-17
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: sex, age, acne severity, acne disease duration, accumulated isotretinoin dose prior to co2 laser and at the end of treatment, VAS score, skin type, weight, medical history
Publications
Waldman A, Bolotin D, Arndt KA, Dover JS, Geronemus RG, Chapas A, Iyengar S, Kilmer SL, Krakowski AC, Lawrence N, Prather HB, Rohrer TE, Schlosser BJ, Kim JYS, Shumaker PR, Spring LK, Alam M. ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use. Dermatol Surg. 2017 Oct;43(10):1249-1262. doi: 10.1097/DSS.0000000000001166.
PubMed 28498204Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.
PubMed 21909457Tasoula E, Gregoriou S, Chalikias J, Lazarou D, Danopoulou I, Katsambas A, Rigopoulos D. The impact of acne vulgaris on quality of life and psychic health in young adolescents in Greece. Results of a population survey. An Bras Dermatol. 2012 Nov-Dec;87(6):862-9. doi: 10.1590/s0365-05962012000600007.
PubMed 23197205Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, Shalita AR, Siegfried EC, Thiboutot DM, Van Voorhees AS, Beutner KA, Sieck CK, Bhushan R; American Academy of Dermatology/American Academy of Dermatology Association. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007 Apr;56(4):651-63. doi: 10.1016/j.jaad.2006.08.048. Epub 2007 Feb 5.
PubMed 17276540Amichai B, Shemer A, Grunwald MH. Low-dose isotretinoin in the treatment of acne vulgaris. J Am Acad Dermatol. 2006 Apr;54(4):644-6. doi: 10.1016/j.jaad.2005.11.1061.
PubMed 16546586Goldstein JA, Socha-Szott A, Thomsen RJ, Pochi PE, Shalita AR, Strauss JS. Comparative effect of isotretinoin and etretinate on acne and sebaceous gland secretion. J Am Acad Dermatol. 1982 Apr;6(4 Pt 2 Suppl):760-5. doi: 10.1016/s0190-9622(82)70066-0.
PubMed 6461679Jones DH, King K, Miller AJ, Cunliffe WJ. A dose-response study of I3-cis-retinoic acid in acne vulgaris. Br J Dermatol. 1983 Mar;108(3):333-43. doi: 10.1111/j.1365-2133.1983.tb03973.x.
PubMed 6219690Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris--10 years later: a safe and successful treatment. Br J Dermatol. 1993 Sep;129(3):292-6. doi: 10.1111/j.1365-2133.1993.tb11849.x.
PubMed 8286227Abergel RP, Meeker CA, Oikarinen H, Oikarinen AI, Uitto J. Retinoid modulation of connective tissue metabolism in keloid fibroblast cultures. Arch Dermatol. 1985 May;121(5):632-5.
PubMed 3994409Cruz NI, Korchin L. Inhibition of human keloid fibroblast growth by isotretinoin and triamcinolone acetonide in vitro. Ann Plast Surg. 1994 Oct;33(4):401-5. doi: 10.1097/00000637-199410000-00007.
PubMed 7810956Sporn MB, Roberts AB, Roche NS, Kagechika H, Shudo K. Mechanism of action of retinoids. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):756-64. doi: 10.1016/s0190-9622(86)70231-4.
PubMed 3021829Manstein 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 15216537Chandrashekar BS, Varsha DV, Vasanth V, Jagadish P, Madura C, Rajashekar ML. Safety of performing invasive acne scar treatment and laser hair removal in patients on oral isotretinoin: a retrospective study of 110 patients. Int J Dermatol. 2014 Oct;53(10):1281-5. doi: 10.1111/ijd.12544. Epub 2014 Jul 11.
PubMed 25039864Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.
PubMed 7955470
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Ablative CO2 Laser Treatment for Acne Scars in Patients Receiving Oral Isotretinoin
- ClinicalTrials.gov ID
- NCT04870489
- Acronym / sponsor ID
- 0629-17
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris;scars; CO2 laser; ISOTRETINOIN;treatments
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 3 May 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.
Isotretinoin is an FDA-approved vitamin A metabolite for the treatment of severe acne; acne that does not respond to other treatments and has a tendency to cause scarring.
Ablative laser treatment is another effective treatment against acne scarring. We believe that the combination of CO2 ablative laser treatment with oral isotretinoin for the treatment of scarring is not only safer but also more effective and leads to much more successful cosmetic results.
Detailed description
Patients treated with Isotretinoin for at least 2 months with doses ranging from 20 mg-40 mg per day were treated with Co2 ablative laser on one side of the face (randomized). Patients will be treated with a single session using the fractional AcuPulse CO2 laser (AcuPulse; Lumenis Inc., Santa Clara, CA), with the AcuScan120™ scanner hand-piece and the Deep FX mode. The treatment areas will be cleansed with a mild cleanser and 70% alcohol. Local anesthesia, comprising a topical eutectic mixture of 2.5% lidocaine hydrochloric acid and 2.5% prilocaine cream (EMLA Cream; Astra Zeneca AB, Sweden), will be applied to the treated side of the face under occlusion before laser therapy. After an hour of application, the anesthetic cream will gently be removed, and then, to obtain a completely dry skin surface.Treatment parameters will be a flounce of 15 mj and density of 15% in single-pass treatment without overlapping pulse. Immediately after the treatment, gauzes moistened with cold saline solution must be gently applied (without rubbing) on the skin for 15-20 minutes. Thereafter a thin layer of mupirocin 2% ointment (TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL) will be applied on the skin.
After the procedure, a visual analog scale (VAS) will be used to determine the amount of pain felt by the participants. No pain will be scored as 0, and intolerable pain will be scored as 10 in this scale. Photographs will be taken at baseline; before each treatment; and 6 months after the last treatment. Acne scars will be graded by using the Quantitative Global Acne Scarring Grading System, which takes into account the quantity and type of scar based on a point system (13). With this grading scale, the total score can vary from 0 to 84. The overall score will be determined as the "acne scar score". All assessments will be done by two independent physicians and the mean value of the two assessments will be calculated. A 25% or less decrease in the acne scar score was defined as "mild improvement", 26-50% decrease as "moderate improvement", 51-75% decrease as "significant improvement", and over 75% as "near total improvement". Lack of decrease in the acne scar score was defined as "no change" and an increase in the score was defined as "worsening".
Subjective self-assessment by the participants were done 6 months after the last treatment and was scored as follows: - 1 as "worsening", 0 as "no change", 1 as "mild improvement", 2 as "moderate improvement", 3 as "significant improvement ", and 4 as "near total improvement". At this point, all patients will be 6 months after cessation of oral isotretinoin and will be treated with CO2 laser to the second half of the face with the same treatment parameters All patients will receive CO2 laser treatment once a month for 3 consecutive months (LASER treatment will be identical to the treatment mentioned above for the first half of the face).
The LASER treatment for the second half of the face will be also evaluated by two independent physicians and will be compared to the first side of the face which was previously treated. Both physicians will not be aware as to which side of the face is treated with laser during oral intake of isotretinoin and which side is not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are treated with Isotretinoin for at least 2 months prior to starting Co2 laser treatment, then they receive laser treatment on one side of the face (randomized) while still taking Isotretinoin; 6 months after cessation of Isotretinoin or any other treatment they are then treated with Co2 laser only on the second side of the face
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin + Co2 ablative laser | Active comparator | Combination Product: Isotretinoin and CO2 laserIsotretinoin treatment while being treated with CO2 laser |
| Co2 ablative laser | Active comparator | Device: Co2 laser6 months to 1 year without isotretinoin treatments to start second side of face with CO2 ablative laser only |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy individuals
- Age 15-60 years old
- Male/Female
- Acne moderate to severe with scarring
- Finished at least 2 months of treatment with Isotretinoin
Key exclusion criteria (6 listed)
- Prior laser treatment for acne scarring
- Patients that have a tendency to have abnormal scarring
- Patients that are immunosuppressed or patients receiving immunosuppressive treatment
- Prior radiotherapy treatment to affected area
- Infected acne
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 |
|---|---|---|
| Isotretinoin and CO2 laserPatients must complete at least 2 months of Isotretinoin prior to starting the study and then continue it for the duration of the 3 months of treatment with the CO2 laser. | Combination product | Isotretinoin + Co2 ablative laser |
| Co2 laserAfter 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment | Device | Co2 ablative laser |
Primary outcome
Quantitative Global Acne Scarring Grading System
Time frame: Photographs taken at baseline; before each treatment; and 6 months after the last treatment
With this acne scars grading scale, the total score can vary from 0 to 84. The overall score will be determined as the "acne scar score". A 25% or less decrease in the acne scar score was defined as "mild improvement", 26-50% decrease as "moderate improvement", 51-75% decrease as "significant improvement", and over 75% as "near total improvement"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Background: PubMed 28498204Waldman A, Bolotin D, Arndt KA, Dover JS, Geronemus RG, Chapas A, Iyengar S, Kilmer SL, Krakowski AC, Lawrence N, Prather HB, Rohrer TE, Schlosser BJ, Kim JYS, Shumaker PR, Spring LK, Alam M. ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use. Dermatol Surg. 2017 Oct;43(10):1249-1262. doi: 10.1097/DSS.0000000000001166.
- Background: PubMed 21909457Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.
- Background: PubMed 23197205Tasoula E, Gregoriou S, Chalikias J, Lazarou D, Danopoulou I, Katsambas A, Rigopoulos D. The impact of acne vulgaris on quality of life and psychic health in young adolescents in Greece. Results of a population survey. An Bras Dermatol. 2012 Nov-Dec;87(6):862-9. doi: 10.1590/s0365-05962012000600007.
- Background: PubMed 17276540Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, Shalita AR, Siegfried EC, Thiboutot DM, Van Voorhees AS, Beutner KA, Sieck CK, Bhushan R; American Academy of Dermatology/American Academy of Dermatology Association. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007 Apr;56(4):651-63. doi: 10.1016/j.jaad.2006.08.048. Epub 2007 Feb 5.
- Background: PubMed 16546586Amichai B, Shemer A, Grunwald MH. Low-dose isotretinoin in the treatment of acne vulgaris. J Am Acad Dermatol. 2006 Apr;54(4):644-6. doi: 10.1016/j.jaad.2005.11.1061.
- Background: PubMed 6461679Goldstein JA, Socha-Szott A, Thomsen RJ, Pochi PE, Shalita AR, Strauss JS. Comparative effect of isotretinoin and etretinate on acne and sebaceous gland secretion. J Am Acad Dermatol. 1982 Apr;6(4 Pt 2 Suppl):760-5. doi: 10.1016/s0190-9622(82)70066-0.
- Background: PubMed 6219690Jones DH, King K, Miller AJ, Cunliffe WJ. A dose-response study of I3-cis-retinoic acid in acne vulgaris. Br J Dermatol. 1983 Mar;108(3):333-43. doi: 10.1111/j.1365-2133.1983.tb03973.x.
- Background: PubMed 8286227Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris--10 years later: a safe and successful treatment. Br J Dermatol. 1993 Sep;129(3):292-6. doi: 10.1111/j.1365-2133.1993.tb11849.x.
- Background: PubMed 3994409Abergel RP, Meeker CA, Oikarinen H, Oikarinen AI, Uitto J. Retinoid modulation of connective tissue metabolism in keloid fibroblast cultures. Arch Dermatol. 1985 May;121(5):632-5.
- Background: PubMed 7810956Cruz NI, Korchin L. Inhibition of human keloid fibroblast growth by isotretinoin and triamcinolone acetonide in vitro. Ann Plast Surg. 1994 Oct;33(4):401-5. doi: 10.1097/00000637-199410000-00007.
- Background: PubMed 3021829Sporn MB, Roberts AB, Roche NS, Kagechika H, Shudo K. Mechanism of action of retinoids. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):756-64. doi: 10.1016/s0190-9622(86)70231-4.
- 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.
- Individual participant dataSharing planned: No. sex, age, acne severity, acne disease duration, accumulated isotretinoin dose prior to co2 laser and at the end of treatment, VAS score, skin type, weight, medical history
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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.
Eli Sprecher, Professor study chair
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isotretinoin and CO2 laser and Co2 laser in people with Acne Vulgaris, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 6 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 13 Jul 2021. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Quantitative Global Acne Scarring Grading System (time frame: Photographs taken at baseline; before each treatment; and 6 months after the last 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 NCT04870489, which also lists 14 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 13 Jul 2021.