Acne VulgarisNCT04433143
Evaluate the Efficacy and Safety of Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Acne
A study testing Minocycline hydrochloride capsules were taken orally in people with Acne Vulgaris, run by Gang Wang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Minocycline hydrochloride capsules were taken orally
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2020to 6 May 2021
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Minocycline hydrochloride capsules were taken orally
- Keywords
- Acne Vulgaris, Intense Pulsed Light, Oral Medication
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline hydrochloride capsules were taken orallyDrug
Also called Intense Pulsed Light
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.
| Study group | Role | What they receive |
|---|---|---|
| oral medication | Experimental | just oral minocycline hydrochloride capsules (100mg/ time, once per day), Receives: Drug: Minocycline hydrochloride capsules were taken orally |
| Intense Pulsed Light single filter | Experimental | Intense pulsed Acne filter Receives: Drug: Minocycline hydrochloride capsules were taken orally |
| Intense Pulsed Light two filters | Experimental | Intense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter) Receives: Drug: Minocycline hydrochloride capsules were taken orally |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from week0 to week24
Secondary outcomes (1)
Pain score
The pain is rated on a scale of 1 to 10
Measured: week0，week4，week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 May 2020
- Primary completion6 May 2021 (estimated)
- Study completion6 May 2021 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Wang, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433143
- Sponsor's protocol ID
- XijingH-PF-20202021-F-1
- Status last verified
- Mar 2021
- First submitted
- 12 Jun 2020
- Last updated
- 12 Mar 2021
- Results posted
- 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 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04433143
- Acronym / sponsor ID
- XijingH-PF-20202021-F-1
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Intense Pulsed Light, Oral Medication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gang WangUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 6 May 2021 (estimated)
- Study completion
- 6 May 2021 (estimated)
- First posted
- 16 Jun 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral medication | Experimental | Drug: Minocycline hydrochloride capsules were taken orallyjust oral minocycline hydrochloride capsules (100mg/ time, once per day), |
| Intense Pulsed Light single filter | Experimental | Drug: Minocycline hydrochloride capsules were taken orallyIntense pulsed Acne filter |
| Intense Pulsed Light two filters | Experimental | Drug: Minocycline hydrochloride capsules were taken orallyIntense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Minocycline hydrochloride capsules were taken orallyAlso: Intense Pulsed LightLumenis 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. | Drug | Intense Pulsed Light single filter, Intense Pulsed Light two filters, oral medication |
Primary outcome
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
1 secondary outcome
Pain score
Time frame: week0，week4，week8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minocycline hydrochloride capsules were taken orally in people with Acne Vulgaris, run by Gang Wang at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 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 China. 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?
Results are not available in the source record.
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?
Acne IGA rating scale (time frame: change from week0 to week24). 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 12 Mar 2021.