CompletedNot Applicable

Evaluation of Broadband Light Treatment Protocol for Pigmented Skin Lesions - A Comparative Study

United States3 participantsStarted 2022-10-01

Plain-language summary

Evaluation of Broadband Light Treatment Protocols for Pigmented Skin Lesions - A comparative study

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy male or female, 18 years or older
✓. Fitzpatrick skin type I-IV
✓. Has visible signs of moderate to severe skin pigmentation
✓. Willing to not use any other procedure(s) in the treatment area during the study, such as laser- or light-based treatment, non-light-based device treatment such as radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler, chemical peel, or surgical procedure
✓. Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study. (applicable to female subjects only)
✓. Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period
✓. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes
✓. Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period

✕. Fitzpatrick skin type V-VI
✕. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
✕. Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
✕. Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
✕. History of malignant tumors in the target area.
✕. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
✕. Pregnant and/or breastfeeding (applicable to female subjects only)
✕. Having an infection, dermatitis or a rash in the treatment area.

Change in pigmentation, skin tone and texture

Timeframe: 4-6 weeks

NCT IDNCT05662592

SponsorSciton

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy male or female, 18 years or older
✓. Fitzpatrick skin type I-IV
✓. Has visible signs of moderate to severe skin pigmentation
✓. Willing to not use any other procedure(s) in the treatment area during the study, such as laser- or light-based treatment, non-light-based device treatment such as radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler, chemical peel, or surgical procedure
✓. Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study. (applicable to female subjects only)
✓. Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period
✓. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes
✓. Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period

✕. Fitzpatrick skin type V-VI
✕. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
✕. Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
✕. Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
✕. History of malignant tumors in the target area.
✕. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
✕. Pregnant and/or breastfeeding (applicable to female subjects only)
✕. Having an infection, dermatitis or a rash in the treatment area.