- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433143
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
- 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.
- 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.
- 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
Enrolling by invitation
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
60
Phase
- 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
-
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Dermatology Derpartment of Xijing Hospital
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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
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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: oral medication
just oral minocycline hydrochloride capsules (100mg/ time, once per day),
|
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:
|
EXPERIMENTAL: Intense Pulsed Light single filter
Intense pulsed Acne filter
|
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:
|
EXPERIMENTAL: Intense Pulsed Light two filters
Intense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter)
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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change from week0 to week24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: week0,week4,week8
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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
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)
May 15, 2020
Primary Completion (ANTICIPATED)
May 6, 2021
Study Completion (ANTICIPATED)
May 6, 2021
Study Registration Dates
First Submitted
June 12, 2020
First Submitted That Met QC Criteria
June 12, 2020
First Posted (ACTUAL)
June 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 12, 2021
Last Update Submitted That Met QC Criteria
March 11, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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