The Effects of Visible Light on the Skin After Administration of Oral Polypodium Leucotomos

NCT02904798 | Completed

• 1 other identifier: IRB#8385
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Polypodium Leucotomos Extract (PLE) is a tropical fern that has antioxidative, photoprotective, chemoprotective, anti-inflammatory, and immunomodulatory properties. The antioxidative effects of PL include inhibition and scavenging of free radicals, lipid peroxidation and reactive oxygen species (ROS) such hydrogen peroxide, superoxide anion, hydroxyl radical and singlet oxygen. Visible light (400-700 nm) causes pigmentation in melanocompetent individuals and induces DNA damage in the human skin through ROS production. The goal of this study is to determine whether the administration of oral PLE has an effect on the development of visible light induced pigmentation.

Conditions

Photodermatoses

Keywords

sunscreen; photoprotection; visible light

Outcome Measures

Primary Outcomes (1)

• Difference in pigmentation pre and post administration of oral PLE

  Detect differences in visible light induced pigmentation pre and post PLE using the following" 1. Investigator Global Assessment Scoring 2. Diffuse Reflectance Spectroscopy 3. Colorimetry 4. Biopsy with melanocyte and melanin stains among other tissue markers 5. Photography

  42 days

Study Arms (1)

Polypodium Leucotomos Extract (PLE)

EXPERIMENTAL

Patient will serve as their own control and will be exposed to 4 doses of visible light on one side of their back prior to receiving PLE. PLE 240mg will be dispensed to patient after evaluation of Pre-PLE visible light doses are evaluated to be taken by the patient for a total of 28 day followed by exposure of the opposite side of the back with the same 4 doses of visible light as above

Drug: Polypodium Leucotomos

Interventions

Polypodium Leucotomos DRUG

\- PL 240mg to be taken by the patient for 28 days prior to irradiation with visible light

Also known as: Helicocare

Polypodium Leucotomos Extract (PLE)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18 and older
• Patients Fitzpatrick III-VI
• Patient able to understand requirements of the study and risks involved
• Patient able to sign a consent form

You may not qualify if:

• A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
• A known history of photosensitivity disorders
• A known history of melanoma or non-melanoma skin cancers
• Those planning on going to the tanning parlors
• Using any of the photosensitizing medication
• A woman who is lactating, pregnant, or planning to become pregnant
• Patient planning on exposing the irradiated or control areas to the sun

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (8)

• Middelkamp-Hup MA, Bos JD, Rius-Diaz F, Gonzalez S, Westerhof W. Treatment of vitiligo vulgaris with narrow-band UVB and oral Polypodium leucotomos extract: a randomized double-blind placebo-controlled study. J Eur Acad Dermatol Venereol. 2007 Aug;21(7):942-50. doi: 10.1111/j.1468-3083.2006.02132.x.

  PMID: 17659004 BACKGROUND

• Middelkamp-Hup MA, Pathak MA, Parrado C, Goukassian D, Rius-Diaz F, Mihm MC, Fitzpatrick TB, Gonzalez S. Oral Polypodium leucotomos extract decreases ultraviolet-induced damage of human skin. J Am Acad Dermatol. 2004 Dec;51(6):910-8. doi: 10.1016/j.jaad.2004.06.027.

  PMID: 15583582 BACKGROUND

• Mahmoud BH, Hexsel CL, Hamzavi IH, Lim HW. Effects of visible light on the skin. Photochem Photobiol. 2008 Mar-Apr;84(2):450-62. doi: 10.1111/j.1751-1097.2007.00286.x. Epub 2008 Jan 29.

  PMID: 18248499 BACKGROUND

• Kollias N, Baqer A. An experimental study of the changes in pigmentation in human skin in vivo with visible and near infrared light. Photochem Photobiol. 1984 May;39(5):651-9. doi: 10.1111/j.1751-1097.1984.tb03905.x. No abstract available.

  PMID: 6739557 BACKGROUND

• Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.

  PMID: 3222167 BACKGROUND

• Mahmoud BH, Ruvolo E, Hexsel CL, Liu Y, Owen MR, Kollias N, Lim HW, Hamzavi IH. Impact of long-wavelength UVA and visible light on melanocompetent skin. J Invest Dermatol. 2010 Aug;130(8):2092-7. doi: 10.1038/jid.2010.95. Epub 2010 Apr 22.

  PMID: 20410914 BACKGROUND

• Hamanaka H, Miyachi Y, Imamura S. Photoprotective effect of topically applied superoxide dismutase on sunburn reaction in comparison with sunscreen. J Dermatol. 1990 Oct;17(10):595-8. doi: 10.1111/j.1346-8138.1990.tb01702.x.

  PMID: 2273160 BACKGROUND

• Mohammad TF, Kohli I, Nicholson CL, Treyger G, Chaowattanapanit S, Nahhas AF, Braunberger TL, Lim HW, Hamzavi IH. Oral Polypodium Leucotomos Extract and Its Impact on Visible Light-Induced Pigmentation in Human Subjects. J Drugs Dermatol. 2019 Dec 1;18(12):1198-1203.

  PMID: 31859468 DERIVED

Study Officials

• Iltefat H Hamzavi, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: September 19, 2016
• Study Start: July 1, 2015
• Primary Completion: February 14, 2017
• Study Completion: April 23, 2017
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

US (1)