Evaluate the Efficacy and Safety of Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Acne

March 11, 2021 updated by: Gang Wang

To Evaluate the Efficacy and Safety of Different Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Moderate to Severe Acne

  1. Acne is a chronic inflammatory disease involving the hair follicles and sebaceous glands, characterized by acne, papules, pustules, nodules, and cysts. Acne often occurs in sebum overflow areas such as the face, chest, back and so on. It is a common skin lesion, which not only affects physical health, but also brings psychological disorders and psychosocial problems to patients. At present, the common treatment methods of acne include health education, topical drugs, oral drugs and medical cosmetic treatment.
  2. Intense pulsed light has been widely accepted as a non-invasive and non-serious treatment for acne. The M22 strong light and laser system Acne filter has a wavelength of 400-600/800-1200nm.
  3. Although there are many treatments for acne, the slow response and easy recurrence of acne are still common problems that trouble doctors and patients. We clinically use drugs combined with intense pulsed light treatment, and the efficacy of the patients is fair, but currently lack of clinical research data support. This study intends to evaluate the effectiveness of different methods in the treatment of moderate and severe acne by evaluating different bands of intense pulsed light combined with drugs, and to observe whether the treatment with oral tetracycline antibiotics combined with intense pulsed light is safe.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The M22 strong light and laser system Acne filter has a wavelength of 400-600/800-1200nm. The light in the 400-600nm band is targeted at the superficial skin inflammation, while 800-1200nm is targeted at the deep sebaceous gland inflammation. The skin can produce oxidation reaction to form singlet oxygen to eliminate propionibacterium acnes after absorption of porphyrin at 400nm. The light of 800-1200nm band can penetrate into the deep layer of sebaceous glands, and the thermal contraction of sebaceous glands can improve the anaerobic environment of bacteria, which is not conducive to the reproduction of bacteria. Meanwhile, when the temperature of sebaceous glands reaches 40 degrees Celsius, bacteria can be killed directly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Dermatology Derpartment of Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-40, regardless of gender; The patient agrees to participate in this trial and signs the informed consent Clinical diagnosis of acne (moderate and severe) No bleeding, rupture, infection or other conditions affecting the visual field of laser surgery.

Exclusion Criteria:

  • Persons with facial dermatitis and sensitive skin; Relevant treatment within 1 month, including topical drugs, oral drugs, medical cosmetic treatment; Those with a history of exposure to the sun in recent January; Persons with scar constitution; Skin malignant tumor or precancerous lesion; Diabetes, heart disease, epilepsy, connective tissue disease, etc.; Pregnant or breastfeeding; Recent skin infections (such as viruses; Bacteria); Those who are using other methods to treat similar diseases; Others are not suitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: oral medication
just oral minocycline hydrochloride capsules (100mg/ time, once per day),
Drug: Minocycline hydrochloride capsules were taken orally
Lumenis OneTM, OPT tender system produced by American Medical Science Company; Use four of the filters. Acne filter has a wavelength of 400-600/800-1200nm. Three pulses were used for treatment, with a pulse width of 5.0ms, a pulse delay of 30ns, and an energy density of 15j /cm2. The instrument parameters were selected according to the skin lesion characteristics, age and tolerance.
Other Names:
  • Intense Pulsed Light
EXPERIMENTAL: Intense Pulsed Light single filter
Intense pulsed Acne filter
Drug: Minocycline hydrochloride capsules were taken orally
Lumenis OneTM, OPT tender system produced by American Medical Science Company; Use four of the filters. Acne filter has a wavelength of 400-600/800-1200nm. Three pulses were used for treatment, with a pulse width of 5.0ms, a pulse delay of 30ns, and an energy density of 15j /cm2. The instrument parameters were selected according to the skin lesion characteristics, age and tolerance.
Other Names:
  • Intense Pulsed Light
EXPERIMENTAL: Intense Pulsed Light two filters
Intense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter)
Drug: Minocycline hydrochloride capsules were taken orally
Lumenis OneTM, OPT tender system produced by American Medical Science Company; Use four of the filters. Acne filter has a wavelength of 400-600/800-1200nm. Three pulses were used for treatment, with a pulse width of 5.0ms, a pulse delay of 30ns, and an energy density of 15j /cm2. The instrument parameters were selected according to the skin lesion characteristics, age and tolerance.
Other Names:
  • Intense Pulsed Light

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acne IGA rating scale
Time Frame: change from week0 to week24
The severity of the facial rash is evaluated according to the number of skin rashes, with a score of 0-5
change from week0 to week24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: week0，week4，week8
The pain is rated on a scale of 1 to 10
week0，week4，week8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gang Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XijingH-PF-20202021-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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