NCT07025837

Brief Summary

This 12-week single-group virtual study evaluates the effects of the iRESTORE Illumina LED Face Mask and Neck \& Chest Mask on skin health in adult females. Participants will use the devices daily for 10 minutes and complete scheduled surveys and photographs to assess improvements in skin appearance via both dermatologist assessment and participant perception.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 14, 2025

Completed
Last Updated

October 14, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

June 10, 2025

Results QC Date

July 4, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

Skin HealthNeck and Chest Mask

Outcome Measures

Primary Outcomes (5)

  • Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in overall skin health.

    Baseline, Week 12

  • Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in fine lines and wrinkles.

    Baseline, Week 12

  • Percentage of Participants Reported as Having an Improvement in Skin Pigmentation as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin pigmentation.

    Baseline, Week 12

  • Percentage of Participants Reported as Having an Improvement in Skin Redness as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin redness.

    Baseline, Week 12.

  • Percentage of Participants Reported as Having an Improvement in Signs of Aging as Evaluated by Dermatologist Grading.

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in signs of aging.

    Baseline, Week 12

Secondary Outcomes (18)

  • Self-Reported Improvement in Overall Skin Hydration

    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  • Self-Reported Improvement in Skin Plumpness

    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  • Self-Reported Improvement in Skin Tone

    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  • Self-Reported Improvement in Skin Texture

    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  • Self-Reported Improvement in Facial Skin Glow

    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  • +13 more secondary outcomes

Study Arms (1)

iRESTORE Illumina LED Device Group

EXPERIMENTAL

All participants will use the iRESTORE LED Face Mask and Neck \& Chest Mask daily for 10 minutes each night. For the face mask, Mode 1 will be used.

Device: iRESTORE Illumina LED Face Mask and Neck & Chest Mask

Interventions

A pair of light-emitting diode (LED) therapy devices designed for at-home use. The facial and neck/chest masks deliver low-level red light therapy through embedded LEDs to improve visible signs of skin aging.

iRESTORE Illumina LED Device Group

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Aged 25-55 years.
  • Willing to follow the study protocols.
  • Self-reported issues with at least two of the following: Fine lines, Wrinkles, Hyperpigmentation, Dark spots, Reduced elasticity
  • Self-report concerns with at least one of the following: Crepey skin on the neck and chest, Sun damage on neck and chest
  • Willing to avoid introducing any new products, prescription medications, or supplements that target skin health during the study period.
  • If taking oral supplements or herbal remedies targeted at skin health and appearance, have been consistently taking these for at least 3 months prior to starting the study.
  • Is willing to maintain the routine of any oral supplements or herbal remedies targeted at skin health and appearance for the duration of the study.
  • Has been using the same skincare routine for at least one month prior to the study start date.
  • Willing to maintain the same skincare routine and products throughout the study.
  • Willing to avoid direct sun exposure during the study duration
  • Willing to wear sunscreen if have to be in the sun

You may not qualify if:

  • Anyone who is extremely satisfied with their skin.
  • Anyone who has any chronic health conditions such as oncological (cancer) or psychiatric disorders.
  • Anyone who is planning to undergo facial treatments during the study period, including botox, dermal filler, chemical peels, etc. or has experienced any of these treatments in the last 3 months.
  • Anyone diagnosed with a skin condition affecting the face and/or neck who has had an active flare-up or breakout within the last year. This includes but is not limited to acne, eczema, psoriasis, rosacea, seborrheic dermatitis, vitiligo, urticaria (hives), warts, atopic dermatitis, melasma, and contact dermatitis.
  • Currently using any prescription medications that may affect the skin condition including but not limited to the following:
  • Corticosteroids like prednisone, methylprednisolone
  • Antipsychotics like olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel)
  • SSRIs and SNRIs like fluoxetine (Prozac), sertraline (Zoloft), venlafaxine (Effexor)
  • Anticonvulsants like phenytoin (Dilantin), lamotrigine (Lamictal), and carbamazepine (Tegretol)
  • Antihypertensives like lisinopril (Zestril), amlodipine (Norvasc), and propranolol (Inderal)
  • Antithyroid medications like Tapazole (methimazole), Propyl-Thyracil (propylthiouracil)
  • Anyone with a history of skin cancer or precancerous skin lesions on the face.
  • Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
  • Anyone who has any known allergies to ingredients commonly found in skincare products.
  • Anyone who is pregnant, breastfeeding, or trying to conceive
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

Results Point of Contact

Title
Patrick Renner
Organization
Citruslabs

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 18, 2025

Study Start

October 14, 2024

Primary Completion

February 5, 2025

Study Completion

February 5, 2025

Last Updated

October 14, 2025

Results First Posted

October 14, 2025

Record last verified: 2025-09

Locations