Evaluate the Efficacy and Safety of Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Acne
Primary Purpose
Acne Vulgaris
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Minocycline hydrochloride capsules were taken orally
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Intense Pulsed Light, Oral Medication
Eligibility Criteria
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.
Sites / Locations
- Dermatology Derpartment of Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
oral medication
Intense Pulsed Light single filter
Intense Pulsed Light two filters
Arm Description
just oral minocycline hydrochloride capsules (100mg/ time, once per day),
Intense pulsed Acne filter
Intense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter)
Outcomes
Primary Outcome Measures
Acne IGA rating scale
The severity of the facial rash is evaluated according to the number of skin rashes, with a score of 0-5
Secondary Outcome Measures
Pain score
The pain is rated on a scale of 1 to 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04433143
Brief Title
Evaluate the Efficacy and Safety of Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Acne
Official Title
To Evaluate the Efficacy and Safety of Different Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Moderate to Severe Acne
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
May 6, 2021 (Anticipated)
Study Completion Date
May 6, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gang Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris, Intense Pulsed Light, Oral Medication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oral medication
Arm Type
Experimental
Arm Description
just oral minocycline hydrochloride capsules (100mg/ time, once per day),
Arm Title
Intense Pulsed Light single filter
Arm Type
Experimental
Arm Description
Intense pulsed Acne filter
Arm Title
Intense Pulsed Light two filters
Arm Type
Experimental
Arm Description
Intense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter)
Intervention Type
Drug
Intervention Name(s)
Minocycline hydrochloride capsules were taken orally
Other Intervention Name(s)
Intense Pulsed Light
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acne IGA rating scale
Description
The severity of the facial rash is evaluated according to the number of skin rashes, with a score of 0-5
Time Frame
change from week0 to week24
Secondary Outcome Measure Information:
Title
Pain score
Description
The pain is rated on a scale of 1 to 10
Time Frame
week0,week4,week8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dermatology Derpartment of Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluate the Efficacy and Safety of Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Acne
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