Skin WhiteningPhase 1NCT01016080
Role of Oral Glutathione in Skin Whitening
A Phase 1 study testing glutathione in people with Skin Whitening, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Skin Whitening
- What is being tested?
- glutathione
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2009to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Adult
Who may be able to join
- Healthy medical students
Who cannot join
- history of skin cancer, especially melanoma
- consumption of any preparations containing glutathione within 1 month of enrollment
- pigmentary disorders or any dermatoses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glutathione as an Oral Whitening Agent: a Randomized, Double-blind, Placebo-controlled Study
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.
- Conditions
- Skin Whitening
- Being tested
- glutathione, placebo
- Keywords
- glutathione, melanin, whitening, UV spots, skin pigment
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutathioneDrug
250 mg capsules, twice daily, orally
placeboDrug
250 mg capsules, twice daily, orally
| Study group | Role | What they receive |
|---|---|---|
| oral glutathione | Active comparator | glutathione, 500 mg, taken orally twice daily Receives: Drug: glutathione |
| placebo capsules | Placebo comparator | identical-appearing placebo capsules Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin melanin index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WhiteningStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016080
- Sponsor's protocol ID
- COA840/2008
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutathione as an Oral Whitening Agent: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01016080
- Acronym / sponsor ID
- COA840/2008
- Conditions
- Skin Whitening
- Keywords
- glutathione, melanin, whitening, UV spots, skin pigment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral glutathione | Active comparator | Drug: glutathioneglutathione, 500 mg, taken orally twice daily |
| placebo capsules | Placebo comparator | Drug: placeboidentical-appearing placebo capsules |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy medical students
Key exclusion criteria (3 listed)
- history of skin cancer, especially melanoma
- consumption of any preparations containing glutathione within 1 month of enrollment
- pigmentary disorders or any dermatoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glutathione250 mg capsules, twice daily, orally | Drug | oral glutathione |
| placebo250 mg capsules, twice daily, orally | Drug | placebo capsules |
Primary outcome
Skin melanin index
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
Related trials for Skin Whitening
Not yet recruiting
Efficacy Validation of Deep Microspicule Cream for Anti-aging and Whitening on Mature Skin
Efficacy Validation of Deep Microspicule Cream for Anti-aging and Whitening on Mature Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing glutathione in people with Skin Whitening, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin melanin index (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2009.