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

NCT04433143 | Unknown

• 1 other identifier: XijingH-PF-20202021-F-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Intense Pulsed Light; Oral Medication

Outcome Measures

Primary Outcomes (1)

• 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

  change from week0 to week24

Secondary Outcomes (1)

• Pain score

  week0，week4，week8

Study Arms (3)

oral medication

EXPERIMENTAL

just oral minocycline hydrochloride capsules (100mg/ time, once per day),

Drug: Minocycline hydrochloride capsules were taken orally

Intense Pulsed Light single filter

EXPERIMENTAL

Intense pulsed Acne filter

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)

Drug: Minocycline hydrochloride capsules were taken orally

Interventions

Minocycline hydrochloride capsules were taken orally DRUG

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.

Also known as: Intense Pulsed Light

Intense Pulsed Light single filter; Intense Pulsed Light two filters; oral medication

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gang Wang: lead

Study Sites (1)

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Minocycline; Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Dermatology

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: May 15, 2020
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)