NCT03716583 (MELADERM) is a Phase 2 clinical trial of Melatonin in Radiation Dermatitis, sponsored by Dennis Bregner Zetner.

Who is sponsoring NCT03716583?

NCT03716583 is sponsored by Dennis Bregner Zetner.

What drugs are being tested in NCT03716583?

Interventions in NCT03716583: Melatonin, Dimethyl Sulfoxide, Placebos.

What condition does NCT03716583 study?

NCT03716583 studies Radiation Dermatitis, Radiation Dermatitis Acute, Breast Cancer.

Is NCT03716583 still recruiting?

NCT03716583 is currently completed. Last updated 10 September 2021.

Last reviewed 2021-09-10 · How we verify

NCT03716583: MELADERM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer

Completed Phase 2 Last updated 10 September 2021

What this trial tests

Phase 2 trial testing Melatonin in Radiation Dermatitis in 48 participants. Completed in 31 January 2021.

Timeline

30 April 2019

Primary endpoint
31 January 2021

31 January 2021

Quick facts

Lead sponsor	Dennis Bregner Zetner
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	48
Start date	30 April 2019
Primary completion	31 January 2021
Estimated completion	31 January 2021
Sites	1 location across Denmark

Drugs / interventions tested

Melatonin (MELATONIN) — full drug profile →
Dimethyl Sulfoxide (DIMETHYL SULFOXIDE) — full drug profile →
Placebos — full drug profile →

Conditions studied

Radiation Dermatitis — all drugs for Radiation Dermatitis →
Radiation Dermatitis Acute — all drugs for Radiation Dermatitis Acute →
Breast Cancer — all drugs for Breast Cancer →

Sponsor

Dennis Bregner Zetner — full company profile →

Who can join

50 and older, female only, with Radiation Dermatitis or Radiation Dermatitis Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Antioxidants for the Treatment of Breast Cancer: Are We There Yet?
Griñan-Lison C, Blaya-Cánovas JL, López-Tejada A, Ávalos-Moreno M, et al · · 2021 · cited 43× · PMID 33572626 · DOI 10.3390/antiox10020205
The scheme, and regulative mechanism of pyroptosis, ferroptosis, and necroptosis in radiation injury.
Ning J, Chen L, Zeng Y, Xiao G, et al · · 2024 · cited 31× · PMID 38481804 · DOI 10.7150/ijbs.91112
Quality-of-life outcomes following topical melatonin application against acute radiation dermatitis in patients with early breast cancer: A double-blind, randomized, placebo-controlled trial.
Zetner D, Kamby C, Gülen S, Christophersen C, et al · · 2023 · cited 12× · PMID 36385713 · DOI 10.1111/jpi.12840
Modulating the Radiation Response for Improved Outcomes in Breast Cancer.
Pesch AM, Pierce LJ, Speers CW. · · 2021 · cited 11× · PMID 34250414 · DOI 10.1200/po.20.00297
Radiomitigators: Breakthroughs in Post-Radiation Recovery.
Obrador E, Estrela JM, López-Blanch R, Moreno-Murciano P, et al · · 2026 · PMID 41897526 · DOI 10.3390/antiox15030381
Beyond Sleeping Disorders, the Role of Melatonin in Skin Diseases and Emerging Applications in Dermatology and Topical Therapy.
Simon JA, Serrano C, Kumar D, Anaya BJ, et al · · 2025 · PMID 41294545 · DOI 10.3390/gels11110860

Verify or expand the search:

Other trials of Melatonin

Trials testing the same drug.

NCT07221968 — Melatonin for the Treatment of DEE-SWAS · Phase 2 · not yet recruiting
NCT07503600 — The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections · Phase 3 · not yet recruiting
NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting

Other recruiting trials for Radiation Dermatitis

Currently open trials in the same condition.

NCT07086638 — ROS-Scavenging Nanozyme Combined With Thermotherapy Alleviate Radiation Dermatitis in Patients With Head and Neck Cancer · NA · recruiting
NCT07081074 — ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head · NA · recruiting
NCT07064577 — Novel ROS-scavenging Nanoenzymes for the Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer · NA · recruiting
NCT06915857 — Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Pr · Phase 3 · recruiting
NCT06729814 — Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fracti · recruiting

Other Dennis Bregner Zetner trials

Trials by the same sponsor.

NCT03519750 — Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03716583 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dennis Bregner Zetner
Last refreshed: 10 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03716583.

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