NCT01016080

Brief Summary

Oral and intravenous glutathione have been used widely to whiten the skin. The investigators tested this hypothesis by giving oral glutathione for 4 weeks to medical students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

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

February 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

3 months

First QC Date

November 17, 2009

Last Update Submit

November 17, 2009

Conditions

Skin Whitening

Keywords

glutathionemelaninwhiteningUV spotsskin pigment

Outcome Measures

Primary Outcomes (1)

  • Skin melanin index

    4 weeks

Study Arms (2)

oral glutathione

ACTIVE COMPARATOR

glutathione, 500 mg, taken orally twice daily

Drug: glutathione

placebo capsules

PLACEBO COMPARATOR

identical-appearing placebo capsules

Drug: placebo

Interventions

glutathioneDRUG

250 mg capsules, twice daily, orally

oral glutathione
placeboDRUG

250 mg capsules, twice daily, orally

placebo capsules

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy medical students

You may not qualify if:

  • history of skin cancer, especially melanoma
  • consumption of any preparations containing glutathione within 1 month of enrollment
  • pigmentary disorders or any dermatoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Pigmentation Disorders

Interventions

Glutathione

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

TH(1)