Acne VulgarisNCT05622253
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema
A study testing Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in people with Acne Vulgaris, run by Zagazig University at 1 site in Egypt.
Trial summary
Acne erythema consists of telangiectasia and erythematous papules, without a comedo, which occurs as a result of inflammatory acne. Moreover, although acne erythema is common in acne patients, no satisfactory medical or surgical treatment is available for this condition. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Adult Patients with acne 2. Patients of both sexes. 3. Willing to sign an informed consent
Who cannot join
- 1. Patients who were taking concomitant acne medication 2. Patients had a history of topical or systemic therapy use for acne for the past 6 months, 3. Patients with a history of photosensitivity reactions 4. Patients with any renal or hepatic compromise or any preexisting hyperlipidemia.
- 5. Pregnant females as well as females who intend to become pregnant during treatment 6. Hypertrophic scar or keloid. 7. Active or recurrent herpes simplex.
Trial locations and contacts
1 site in 1 country.
About this study
Acne erythema consists of telangiectasia and erythematous papules, without a comedo, which occurs as a result of inflammatory acne. Moreover, although acne erythema is common in acne patients, no satisfactory medical or surgical treatment is available for this condition. Some acne erythema lesions may improve with time, but the persistent acne erythema, which is experienced by most patients, is cosmetically unacceptable and leads to frustration and psychological distress.
Read the detailed description
Up to the present time, there have been several studies on the clinical efficacy of different laser modalities for acne treatment. Pulsed dye laser (PDL), 585 or 595 nm, has been demonstrated as one of the effective treatment options Another laser long-pulsed neodymium: yttrium-aluminum-garnet (Nd:YAG) laser with 1064 nm has been commonly used for skin rejuvenation. Nevertheless, the efficacy of this laser for acne treatment has been shown in some studies and case reports. The therapeutic effect on acne lesions is believed to be mediated by the selective photothermolysis of vessels, the upregulation of TGF-β, the reduction of interleukin-8 (IL-8) and Toll-like receptors-2 (TLR-2), and the thermal destruction of sebaceous glands.
Isotretinoin remains the mainstay of acne treatment. No doubt, the side effects of this effective drug holds physicians back from jumping to prescribe it. Recent data suggested that lower doses (0.25 mg/kg/day) may lead to fewer side effects. and fewer flares. Clearing the use of oral isotretinoin in combination with other procedures has expanded our therapeutic options to obtain better control.
- Conditions
- Acne Vulgaris
- Being tested
- Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG LaserCombination product
Selected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval.
| Study group | Role | What they receive |
|---|---|---|
| Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema | Experimental | Selected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval. Receives: Combination Product: Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of acne erythema was determined on the 4-point grading of acne erythema
0 None Clear
- Mild Faintly detectable erythema, light pink
- Moderate Dull red, clearly distinguishable
- severe Deep/dark red
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Mar 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Essam, Zagazig University
- Investigators
- Reham Essam, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622253
- Sponsor's protocol ID
- 5566-RE
- Status last verified
- Apr 2023
- First submitted
- 12 Nov 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema
- ClinicalTrials.gov ID
- NCT05622253
- Acronym / sponsor ID
- 5566-RE
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 18 Nov 2022 (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.
Acne erythema consists of telangiectasia and erythematous papules, without a comedo, which occurs as a result of inflammatory acne. Moreover, although acne erythema is common in acne patients, no satisfactory medical or surgical treatment is available for this condition. Some acne erythema lesions may improve with time, but the persistent acne erythema, which is experienced by most patients, is cosmetically unacceptable and leads to frustration and psychological distress.
Detailed description
Up to the present time, there have been several studies on the clinical efficacy of different laser modalities for acne treatment. Pulsed dye laser (PDL), 585 or 595 nm, has been demonstrated as one of the effective treatment options Another laser long-pulsed neodymium: yttrium-aluminum-garnet (Nd:YAG) laser with 1064 nm has been commonly used for skin rejuvenation. Nevertheless, the efficacy of this laser for acne treatment has been shown in some studies and case reports. The therapeutic effect on acne lesions is believed to be mediated by the selective photothermolysis of vessels, the upregulation of TGF-β, the reduction of interleukin-8 (IL-8) and Toll-like receptors-2 (TLR-2), and the thermal destruction of sebaceous glands.
Isotretinoin remains the mainstay of acne treatment. No doubt, the side effects of this effective drug holds physicians back from jumping to prescribe it. Recent data suggested that lower doses (0.25 mg/kg/day) may lead to fewer side effects. and fewer flares. Clearing the use of oral isotretinoin in combination with other procedures has expanded our therapeutic options to obtain better control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema | Experimental | Combination Product: Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG LaserSelected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Adult Patients with acne 2. Patients of both sexes. 3. Willing to sign an informed consent
Key exclusion criteria (2 listed)
- 1. Patients who were taking concomitant acne medication 2. Patients had a history of topical or systemic therapy use for acne for the past 6 months, 3. Patients with a history of photosensitivity reactions 4. Patients with any renal or hepatic compromise or any preexisting hyperlipidemia.
- 5. Pregnant females as well as females who intend to become pregnant during treatment 6. Hypertrophic scar or keloid. 7. Active or recurrent herpes simplex.
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 |
|---|---|---|
| Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG LaserSelected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval. | Combination product | Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema |
Primary outcome
The degree of acne erythema was determined on the 4-point grading of acne erythema
Time frame: 4 months
0 None Clear 1. Mild Faintly detectable erythema, light pink 2. Moderate Dull red, clearly distinguishable 3. severe Deep/dark red
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 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Essam, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in people with Acne Vulgaris, run by Zagazig University at 1 site 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 2 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 4 Apr 2023. 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?
The degree of acne erythema was determined on the 4-point grading of acne erythema (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2023.