Effects of a superpotent melanotropic peptide in combination with solar UV radiation on tanning of the skin in human volunteers

Robert T Dorr, Gregory Ertl, Norman Levine, Chris Brooks, Jerry L. Bangert, Marianne Broome Powell, Stuart Humphrey, David S Alberts

Research output: Contribution to journalArticle

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Abstract

Objective: Three phase 1 clinical trials of a superpotent melanotropic peptide, metanotan-1 (MT-1, or [Nle4-D-Phe7] α-melanocyte-stimulating hormone) were performed to demonstrate safety for MT-1 therapy combined with UV-B light or sunlight. Design: Open-label studies at 2 dose levels of MT-1 combined with small doses of UV-B to the neck or buttock or full sunlight to half of the back. Setting: Dermatology clinics at the Arizona Health Sciences Center, Tucson. Interventions: The first study randomized 4 subjects to MT-1 (0.08 mg/kg per day subcutaneously) and 4 subjects to injections of isotonic sodium chloride (9%) solution for 10 days, followed by neck irradiation with 3 times the minimal erythema dose (MED) of UV-B light. In the next study (n = 12), the MT-1 dosage was increased to 0.16 mg/kg per day for 10 days, with UV-B radiation (0.25-0.75 MED) given to a buttock site for 5 days during (n = 7) or after (n = 5) MT-1 administration. A final study randomized 8 subjects to 3 to 5 days of sunlight to half of the back or to sunlight plus 0.16 mg/kg of MT-1 for 5 days per week for 4 weeks. Results. Tanning in the first study was achieved in 3 of 4 subjects receiving MT-1, and these subjects also had 47% fewer sunburn cells at the irradiated neck site. More skin sites darkened with the higher dose of MT-1 in the second study. In the third study, there was significantly enhanced tanning of the back in the MT-1 group, and this was maintained at least 3 weeks longer than the tanning in the sunlight-only controls, who required 50% more sun-exposure time for equivalent tanning. Main Outcome Measure: There were no pathologic findings at any UV-B or sun-exposed sites in any subject. Toxic effects due to MT-1 were minor, consisting of nausea and transient facial flushing. Conclusion: Melanotan-1 can be safely combined with UV-B light or sunlight and appears to act synergistically in the tanning response to light.

Original languageEnglish (US)
Pages (from-to)827-835
Number of pages9
JournalArchives of Dermatology
Volume140
Issue number7
DOIs
StatePublished - Jul 2004

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Tanning
Sunlight
Volunteers
Radiation
Skin
Peptides
Ultraviolet Rays
Buttocks
Neck
Solar System
Erythema
Sunburn
Melanocyte-Stimulating Hormones
Clinical Trials, Phase I
Poisons
Dermatology
Sodium Chloride
Nausea
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Dermatology

Cite this

Effects of a superpotent melanotropic peptide in combination with solar UV radiation on tanning of the skin in human volunteers. / Dorr, Robert T; Ertl, Gregory; Levine, Norman; Brooks, Chris; Bangert, Jerry L.; Powell, Marianne Broome; Humphrey, Stuart; Alberts, David S.

In: Archives of Dermatology, Vol. 140, No. 7, 07.2004, p. 827-835.

Research output: Contribution to journalArticle

Dorr, Robert T ; Ertl, Gregory ; Levine, Norman ; Brooks, Chris ; Bangert, Jerry L. ; Powell, Marianne Broome ; Humphrey, Stuart ; Alberts, David S. / Effects of a superpotent melanotropic peptide in combination with solar UV radiation on tanning of the skin in human volunteers. In: Archives of Dermatology. 2004 ; Vol. 140, No. 7. pp. 827-835.
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abstract = "Objective: Three phase 1 clinical trials of a superpotent melanotropic peptide, metanotan-1 (MT-1, or [Nle4-D-Phe7] α-melanocyte-stimulating hormone) were performed to demonstrate safety for MT-1 therapy combined with UV-B light or sunlight. Design: Open-label studies at 2 dose levels of MT-1 combined with small doses of UV-B to the neck or buttock or full sunlight to half of the back. Setting: Dermatology clinics at the Arizona Health Sciences Center, Tucson. Interventions: The first study randomized 4 subjects to MT-1 (0.08 mg/kg per day subcutaneously) and 4 subjects to injections of isotonic sodium chloride (9{\%}) solution for 10 days, followed by neck irradiation with 3 times the minimal erythema dose (MED) of UV-B light. In the next study (n = 12), the MT-1 dosage was increased to 0.16 mg/kg per day for 10 days, with UV-B radiation (0.25-0.75 MED) given to a buttock site for 5 days during (n = 7) or after (n = 5) MT-1 administration. A final study randomized 8 subjects to 3 to 5 days of sunlight to half of the back or to sunlight plus 0.16 mg/kg of MT-1 for 5 days per week for 4 weeks. Results. Tanning in the first study was achieved in 3 of 4 subjects receiving MT-1, and these subjects also had 47{\%} fewer sunburn cells at the irradiated neck site. More skin sites darkened with the higher dose of MT-1 in the second study. In the third study, there was significantly enhanced tanning of the back in the MT-1 group, and this was maintained at least 3 weeks longer than the tanning in the sunlight-only controls, who required 50{\%} more sun-exposure time for equivalent tanning. Main Outcome Measure: There were no pathologic findings at any UV-B or sun-exposed sites in any subject. Toxic effects due to MT-1 were minor, consisting of nausea and transient facial flushing. Conclusion: Melanotan-1 can be safely combined with UV-B light or sunlight and appears to act synergistically in the tanning response to light.",
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AU - Dorr, Robert T

AU - Ertl, Gregory

AU - Levine, Norman

AU - Brooks, Chris

AU - Bangert, Jerry L.

AU - Powell, Marianne Broome

AU - Humphrey, Stuart

AU - Alberts, David S

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N2 - Objective: Three phase 1 clinical trials of a superpotent melanotropic peptide, metanotan-1 (MT-1, or [Nle4-D-Phe7] α-melanocyte-stimulating hormone) were performed to demonstrate safety for MT-1 therapy combined with UV-B light or sunlight. Design: Open-label studies at 2 dose levels of MT-1 combined with small doses of UV-B to the neck or buttock or full sunlight to half of the back. Setting: Dermatology clinics at the Arizona Health Sciences Center, Tucson. Interventions: The first study randomized 4 subjects to MT-1 (0.08 mg/kg per day subcutaneously) and 4 subjects to injections of isotonic sodium chloride (9%) solution for 10 days, followed by neck irradiation with 3 times the minimal erythema dose (MED) of UV-B light. In the next study (n = 12), the MT-1 dosage was increased to 0.16 mg/kg per day for 10 days, with UV-B radiation (0.25-0.75 MED) given to a buttock site for 5 days during (n = 7) or after (n = 5) MT-1 administration. A final study randomized 8 subjects to 3 to 5 days of sunlight to half of the back or to sunlight plus 0.16 mg/kg of MT-1 for 5 days per week for 4 weeks. Results. Tanning in the first study was achieved in 3 of 4 subjects receiving MT-1, and these subjects also had 47% fewer sunburn cells at the irradiated neck site. More skin sites darkened with the higher dose of MT-1 in the second study. In the third study, there was significantly enhanced tanning of the back in the MT-1 group, and this was maintained at least 3 weeks longer than the tanning in the sunlight-only controls, who required 50% more sun-exposure time for equivalent tanning. Main Outcome Measure: There were no pathologic findings at any UV-B or sun-exposed sites in any subject. Toxic effects due to MT-1 were minor, consisting of nausea and transient facial flushing. Conclusion: Melanotan-1 can be safely combined with UV-B light or sunlight and appears to act synergistically in the tanning response to light.

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