Striae GravidarumPhase 3NCT04956367
Efficacy of Fractional Carbon Dioxide Laser Combined With Platelet-rich Plasma
A Phase 3 study testing Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma and CO2 laser with PRP in people with Striae Gravidarum, run by Jose R. Reyes Memorial Medical Center at 1 site in Philippines.
Trial summary
This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Striae Gravidarum
- What is being tested?
- Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma and CO2 laser with PRP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Jul 2019to 30 Nov 2019
- Phase
- Phase 3
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum patients with ages 18 to 45 years
- Fitzpatrick skin type III-V
- having bilateral symmetrical SG of red, white or a combination of both types.
Who cannot join
- pregnancy
- breastfeeding
- heavy consumption of alcoholic beverages
- dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis
- uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease;
- elevated liver function tests (SGPT, SGOT), and serum creatinine;
Show all 9Show fewer
- intake of any medications that may influence the outcome of the study;
- intake of any vitamins/minerals or any supplements in the past 6 months; and
- application of any topical agents (e.g., whitening, anti-aging) in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ablative Fractional Carbon Dioxide Laser Combined With Autologous Platelet-rich Plasma Versus Ablative Fractional Carbon Dioxide Laser and Placebo in the Treatment of Striae Gravidarum: a Randomized Clinical Trial
This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women.
- Conditions
- Striae Gravidarum
- Being tested
- Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma, CO2 laser with PRP, CO2 laser with placebo
- Keywords
- Striae Gravidarum, carbon dioxide laser, platelet-rich plasma
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasmaProcedure or surgery
Carbon dioxide laser (Smaxel.878.4810) was FDA-approved device used in dermatology practice. PRP was described as having growth factors to be used to promote healing.
CO2 laser with PRPDevice
CO2 laser with PRP
CO2 laser with placeboDevice
CO2 laser with placebo
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser with PRP | Experimental | After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, PRP will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals. Receives: Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma; Device: CO2 laser with PRP |
| CO2 laser with placebo | Placebo comparator | After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, pNSS will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals. Receives: Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma; Device: CO2 laser with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Change in appearance based from clinical photos done in baseline, week 6, week 10, week 14 and week 16 . This will be assessed by quartile grading scale (poor, <25% improvement; fair, 25-50% improvement; good, 51-75% improvement; and excellent, >75% improvement)
Measured: 16 weeks
Secondary outcomes (1)
Patient satisfaction rate
Self-reported by the patient using a quartile grading system with the following grades: 0 as poor; 1 as fair; 2 as satisfied; or 3 as very satisfied. The rating will be done at weeks 6, 10, 14 and 16.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jul 2019
- Primary completion31 Oct 2019
- Study completion30 Nov 2019
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 Striae GravidarumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose R. Reyes Memorial Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ivan Arni Preclaro, Jose R. Reyes Memorial Medical Center
- Investigators
- Ivan Arni C Preclaro, MD, Principal investigator, Jose R. Reyes Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956367
- Sponsor's protocol ID
- 2019-054
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Faghihi G, Keyvan S, Asilian A, Nouraei S, Behfar S, Nilforoushzadeh MA. Efficacy of autologous platelet-rich plasma combined with fractional ablative carbon dioxide resurfacing laser in treatment of facial atrophic acne scars: A split-face randomized clinical trial. Indian J Dermatol Venereol Leprol. 2016 Mar-Apr;82(2):162-8. doi: 10.4103/0378-6323.174378.
PubMed 26924405
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ablative Fractional Carbon Dioxide Laser Combined With Autologous Platelet-rich Plasma Versus Ablative Fractional Carbon Dioxide Laser and Placebo in the Treatment of Striae Gravidarum: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04956367
- Acronym / sponsor ID
- 2019-054
- Conditions
- Striae Gravidarum
- Keywords
- Striae Gravidarum, carbon dioxide laser, platelet-rich plasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jose R. Reyes Memorial Medical CenterOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 9 Jul 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.
This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 laser with PRP | Experimental | Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma, Device: CO2 laser with PRPAfter anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, PRP will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals. |
| CO2 laser with placebo | Placebo comparator | Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma, Device: CO2 laser with placeboAfter anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, pNSS will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Postpartum patients with ages 18 to 45 years
- Fitzpatrick skin type III-V
- having bilateral symmetrical SG of red, white or a combination of both types.
Key exclusion criteria (9 listed)
- pregnancy
- breastfeeding
- heavy consumption of alcoholic beverages
- dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis
- uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease;
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 |
|---|---|---|
| Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasmaCarbon dioxide laser (Smaxel.878.4810) was FDA-approved device used in dermatology practice. PRP was described as having growth factors to be used to promote healing. | Procedure or surgery | CO2 laser with PRP, CO2 laser with placebo |
| CO2 laser with PRPCO2 laser with PRP | Device | CO2 laser with PRP |
| CO2 laser with placeboCO2 laser with placebo | Device | CO2 laser with placebo |
Primary outcome
Clinical improvement
Time frame: 16 weeks
Change in appearance based from clinical photos done in baseline, week 6, week 10, week 14 and week 16 . This will be assessed by quartile grading scale (poor, <25% improvement; fair, 25-50% improvement; good, 51-75% improvement; and excellent, >75% improvement)
1 secondary outcome
Patient satisfaction rate
Time frame: 16 weeks
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 9 Jul 2021.
- Results publication: PubMed 26924405Faghihi G, Keyvan S, Asilian A, Nouraei S, Behfar S, Nilforoushzadeh MA. Efficacy of autologous platelet-rich plasma combined with fractional ablative carbon dioxide resurfacing laser in treatment of facial atrophic acne scars: A split-face randomized clinical trial. Indian J Dermatol Venereol Leprol. 2016 Mar-Apr;82(2):162-8. doi: 10.4103/0378-6323.174378.
- Individual participant dataSharing planned: No
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.
Ivan Arni C Preclaro, MD principal investigator
Jose R. Reyes Memorial 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 3 study testing Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma and CO2 laser with PRP in people with Striae Gravidarum, run by Jose R. Reyes Memorial Medical Center at 1 site in Philippines.
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 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 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 Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical improvement (time frame: 16 weeks). 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 NCT04956367, 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 9 Jul 2021.