GlutathionePhase 1NCT04105504
Oral Glutathione As A Skin Whitening Agent
A Phase 1 study testing Glutathione in people with Glutathione and Skin Whitening, run by Dr Irma Bernadette S Sitohang at 1 site in Indonesia.
Trial summary
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glutathione, 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
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Apr 2018to 1 Aug 2018
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with skin type Fitzpatrick IV and V
- Women aged from 30 to 55 years with an understanding of all the information given by a written consent form
- Working indoor office jobs (for minimum 8 hours)
Who cannot join
- Personal or family history of skin cancer, especially melanoma
- Consumption of any preparations containing glutathione within 1 month of enrollment
- Use of any topical skin brightening or whitening preparations within 1 month of enrollment
- Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas
- A pregnant or breastfeeding mother
- Personal history of drug allergy or skin disorder due to side effects of oral therapy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, 10430
About this study
Official title: Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
Read the detailed description
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent.
The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.
Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit.
At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
- Conditions
- Glutathione, Skin Whitening
- Being tested
- Glutathione, Placebo oral tablet
- Keywords
- glutathione, whitening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutathioneDrug
Also called L-Gluthatione
Oral glutathione capsule (500 mg), were taken once daily by the subjects.
Placebo oral tabletDrug
Placebo oral capsule were taken once daily by the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Glutathione Group | Experimental | Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Receives: Drug: Glutathione |
| Placebo Group | Placebo comparator | Subjects were randomised to receive Placebo capsules, which were identical in appearance and packaged in identical-looking containers with the Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Spot UV at 4 weeks
Total reduction (improvement) of spot UV
Measured: 4 weeks
Change from Baseline Spot Polarization at 4 weeks
Total reduction (improvement) of spot polarization
Measured: 4 weeks
Change from Baseline Skin Tone at 4 weeks
Improvement of skin tone
Measured: 4 weeks
Change from Baseline Spot UV at 8 weeks
Total reduction (improvement) of spot UV
Measured: 8 weeks
Change from Baseline Spot Polarization at 8 weeks
Total reduction (improvement) of spot polarization
Measured: 8 weeks
Change from Baseline Skin Tone at 8 weeks
Improvement of skin tone
Measured: 8 weeks
Change from Baseline Spot UV at 12 weeks
Total reduction (improvement) of spot UV
Measured: 12 weeks
Change from Baseline Spot Polarization at 12 weeks
Total reduction (improvement) of spot polarization
Measured: 12 weeks
Change from Baseline Skin Tone at 12 weeks
Improvement of skin tone
Measured: 12 weeks
Secondary outcomes (6)
Subjective Improvement at 4 weeks
Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
- minimal improvement
- moderate improvement
- good improvement
- excellent improvement
Note: The higher improvement represents a better outcome.
Measured: 4 weeks
Adverse events at 4 weeks
Adverse events related to therapy
Measured: 4 weeks
Subjective Improvement at 8 weeks
Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
- minimal improvement
- moderate improvement
- good improvement
- excellent improvement
Note: The higher improvement represents a better outcome.
Measured: 8 weeks
Adverse events at 8 weeks
Adverse events related to therapy
Measured: 8 weeks
Subjective Improvement at 12 weeks
Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
- minimal improvement
- moderate improvement
- good improvement
- excellent improvement
Note: The higher improvement represents a better outcome.
Measured: 12 weeks
Adverse events at 12 weeks
Adverse events related to therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start8 Apr 2018
- Primary completion6 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlutathioneStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Irma Bernadette S Sitohang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Irma Bernadette S Sitohang, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105504
- Sponsor's protocol ID
- RCTGlutathione
- Status last verified
- Sep 2019
- First submitted
- 8 Aug 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sitohang IBS, Anwar AI, Jusuf NK, Arimuko A, Norawati L, Veronica S. Evaluating Oral Glutathione Plus Ascorbic Acid, Alpha-lipoic Acid, and Zinc Aspartate as a Skin-lightening Agent: An Indonesian Multicenter, Randomized, Controlled Trial. J Clin Aesthet Dermatol. 2021 Jul;14(7):E53-E58. Epub 2021 Jul 1.
PubMed 34840651
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04105504
- Acronym / sponsor ID
- RCTGlutathione
- Conditions
- Glutathione, Skin Whitening
- Keywords
- glutathione, whitening
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr Irma Bernadette S SitohangUniversity, hospital or other
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 26 Sep 2019 (actual)
- 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.
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
Detailed description
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent.
The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.
Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit.
At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutathione Group | Experimental | Drug: GlutathioneSubjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. |
| Placebo Group | Placebo comparator | Drug: Placebo oral tabletSubjects were randomised to receive Placebo capsules, which were identical in appearance and packaged in identical-looking containers with the Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects with skin type Fitzpatrick IV and V
- Women aged from 30 to 55 years with an understanding of all the information given by a written consent form
- Working indoor office jobs (for minimum 8 hours)
Key exclusion criteria (6 listed)
- Personal or family history of skin cancer, especially melanoma
- Consumption of any preparations containing glutathione within 1 month of enrollment
- Use of any topical skin brightening or whitening preparations within 1 month of enrollment
- Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas
- A pregnant or breastfeeding mother
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 |
|---|---|---|
| GlutathioneAlso: L-GluthationeOral glutathione capsule (500 mg), were taken once daily by the subjects. | Drug | Glutathione Group |
| Placebo oral tabletPlacebo oral capsule were taken once daily by the subjects. | Drug | Placebo Group |
Primary outcome
Change from Baseline Spot UV at 4 weeks
Time frame: 4 weeks
Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 4 weeks
Time frame: 4 weeks
Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 4 weeks
Time frame: 4 weeks
Improvement of skin tone
Change from Baseline Spot UV at 8 weeks
Time frame: 8 weeks
Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 8 weeks
Time frame: 8 weeks
Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 8 weeks
Time frame: 8 weeks
Improvement of skin tone
Change from Baseline Spot UV at 12 weeks
Time frame: 12 weeks
Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 12 weeks
Time frame: 12 weeks
Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 12 weeks
Time frame: 12 weeks
Improvement of skin tone
6 secondary outcomes
Subjective Improvement at 4 weeks
Time frame: 4 weeks
Adverse events at 4 weeks
Time frame: 4 weeks
Subjective Improvement at 8 weeks
Time frame: 8 weeks
Adverse events at 8 weeks
Time frame: 8 weeks
Subjective Improvement at 12 weeks
Time frame: 12 weeks
Adverse events at 12 weeks
Time frame: 12 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 26 Sep 2019.
- Derived from this study: PubMed 34840651Sitohang IBS, Anwar AI, Jusuf NK, Arimuko A, Norawati L, Veronica S. Evaluating Oral Glutathione Plus Ascorbic Acid, Alpha-lipoic Acid, and Zinc Aspartate as a Skin-lightening Agent: An Indonesian Multicenter, Randomized, Controlled Trial. J Clin Aesthet Dermatol. 2021 Jul;14(7):E53-E58. Epub 2021 Jul 1.
- Individual participant dataSharing planned: No
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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 Glutathione and Skin Whitening, run by Dr Irma Bernadette S Sitohang at 1 site in Indonesia.
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 3 inclusion and 6 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 26 Sep 2019. 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 Indonesia. 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?
Change from Baseline Spot UV at 4 weeks (time frame: 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105504, which also lists 1 linked publication.
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 26 Sep 2019.