Capillus LED Face Mask Clinical Use Protocol

Standardized Operating Procedure for Home-Based Facial Photobiomodulation Therapy

1. Purpose and Scope

This protocol provides standardized guidance for the safe and effective use of the Capillus LED Face Mask for at-home facial photobiomodulation therapy (PBMT).

2. Intended Use & Clinical Applications

The Capillus LED Face Mask is a non-invasive, wearable phototherapy device designed to deliver visible red, blue, and combined-spectrum light to the facial surface. Documented applications include:

• Improvement in facial skin texture, tone, and radiance

• Reduction in fine lines and wrinkles through collagen stimulation

• Adjunctive treatment for mild-to-moderate acne vulgaris

• Supportive care for post-inflammatory hyperpigmentation

• General facial rejuvenation and dermal wellness

The device is intended for home use by adults, following consultation with a healthcare professional when appropriate.

3. Mechanism of Action (Overview)

• Red Light (Approx. 630–660 nm): Promotes fibroblast activity, increases collagen and elastin synthesis, supports circulation and dermal repair.

• Near-Infrared Light (Approx. 810–850 nm): Reaches deeper tissues, supporting mitochondrial ATP production and cellular recovery.

• Blue Light (Approx. 405–470 nm): Exhibits antibacterial effects on Cutibacterium acnes, reducing acne lesions and inflammatory response.

• Pink/Combination Mode: Blends wavelengths to support pigmentation management, photodynamic antibacterial action, and inflammation reduction.

4. Standard Treatment Protocol

Administration Requirements

• Perform treatment on clean, fully dry skin.

• Remove sunscreen, heavy moisturizers, occlusives, and makeup before use.

• Do not use concurrently with photosensitizing agents unless medically cleared.

5. 30-Day Progressive Treatment Program

Designed to optimize patient adherence, reduce skin irritation risk, and evaluate responsiveness.

Patients with sensitive or reactive skin may reduce frequency to every other day, based on tolerance.

6. Contraindications

Use is not recommended in individuals who have:

• Known photosensitivity or light-triggered conditions

• Active facial infections, open wounds, or undiagnosed skin lesions

• Implanted electronic or metallic facial devices

• Epilepsy or seizure disorders triggered by light exposure

• Pregnancy (unless cleared by a physician)

• Any contraindication listed in the manufacturer's IFU

7. Precautions & Safety Guidance

• Ensure the mask fits securely and does not obstruct vision or breathing.

• Minor warmth during treatment is expected; discontinue if heat becomes uncomfortable.

• Avoid direct staring into LEDs.

• If erythema, burning, dizziness, or persistent discomfort occurs, discontinue therapy and seek medical evaluation.

• Do not exceed recommended treatment duration unless advised by a clinician.

• Avoid self-modification, disassembly, or unauthorized repair of the device.

9. Cleaning, Storage, and Device Care

• Wipe interior and exterior surfaces with a soft cloth and non-abrasive, alcohol-free cleanser.

• Allow the device to dry completely before storage.

• Store in a cool, dry environment away from heat, moisture, and direct sunlight.

• Do not fold, crush, or place heavy objects on the device.

10. Troubleshooting & Maintenance

Inspect the device and cords before each use. Discontinue if structural or electrical damage is observed.

If the device does not power on:

• Confirm all cable connections

• Verify functioning electrical outlet

• Restart controller

If LEDs fail to illuminate:

• Reconnect controller

• Reset the power source

If excessive heat develops:

• Stop the session immediately

• Allow the device to cool and reassess intensity/tolerance

For unresolved issues, contact Capillus Technical Support.