Pigmentation From Visible LightNCT01927679
Vitamin E Prevention of Visible Light Pigmentation
A study testing Vitamin E and Eucerin in people with Pigmentation From Visible Light, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
The main objective of the study is to assess the efficacy of an antioxidant in preventing pigmentation induced by visible light in subjects with a phototype IV or V. Patients will be exposed to a range of visible light to areas on the back to confirm study eligibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pigmentation From Visible Light
- What is being tested?
- Vitamin E and Eucerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Nov 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women 18 years of age or older at time of consent.
- Subject, male or female, is willing to use effective contraceptive method for at least 30 days before Day -7 and at least until Day 7±1. Effective contraceptive methods are:
- Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
- Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
- Intrauterine device (IUD);
- Sterilization such as tubal ligation, hysterectomy or vasectomy;
Show all 13Show fewer
- Postmenopausal state for at least 1 year for female subject or female partner of male subject;
- Same-sex partner;
- Abstinence.
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
- Skin phototype IV and V
- Exhibits visible light-induced pigmentation at Day 0
- Is willing to avoid exposure to UV radiation, including sunlight, phototherapy, or tanning salon, on the back for the duration of the study and 4 weeks preceding the study.
Who cannot join
- Current pregnancy or lactation
- Allergy to any of the products used in the study
- Use of phototherapy or tanning beds within the 30 days of the study start (Day -7)
- Use of photosensitizing medication within the 30 days or 5 half-lives (whichever is longest) from the study start (Day-7)
- Use of products other than the ones used in the study that may alter the pigmentation of the skin
- Skin condition or medical condition altering the appearance of the skin in the area to be irradiated that would interfere with pigmentation evaluation
Show all 10Show fewer
- Medical condition or medication putting at undue risk
- Medical condition that is unstable at the time of the study or that may interfere with the study
- History of organ transplant
- Pigmentation on the back is difficult to evaluate due to excessive hair or presence of a tattoo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin E in the Prevention of Visible Light Induced Pigmentation
The main objective of the study is to assess the efficacy of an antioxidant in preventing pigmentation induced by visible light in subjects with a phototype IV or V.
Patients will be exposed to a range of visible light to areas on the back to confirm study eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible to continue.
Read more
Eligible patients will have study product applied to part of the back and placebo on another part of the back. The placebo area will be exposed to the same range of light based as at Day -7. The area where the antioxidant is applied will have a higher range of light exposure than the area without the study product.
Seven days later, the areas will be examined to determine the lowest exposure inducing pigmentation on the sides with placebo and with antioxidant. The color will also be measured between two identical exposures with placebo and with antioxidant.
Read the detailed description
At Day -7, all subjects will be exposed to a pre-specified range of doses of visible light on 6 areas of the back, each measuring 0.9 cm^2 in order to evaluate their pigmentary response to visible light. The doses will be 20, 40, 80, 160, 320 and 640 J/cm^2. At Day 0, a visual inspection will establish which subjects qualify for the remainder of the study, based on the presence or absence of pigmentation induced by visible light. Subjects who do not exhibit pigmentation at 640 J/cm^2 or lower will not pursue the study.
Subjects who demonstrate pigmentation will move on to the next step of the study. On this same Day 0 visit, these subjects will be randomized to receive a topical antioxidant preparation on one of two halves of their back and a control on the other side. The antioxidant and control will be applied twice before the exposure to visible light is done on Day 1: 24 hours prior (Day 0) and 30 minutes prior (Day 1) exposure. On Day 1, the skin with antioxidant will be exposed to fluences of 80, 160, 320, 640, 1280 and 1920 J/cm^2 whereas that with control will be exposed to the same lower doses as on Day -7. This will be done on a total of 12 different areas of 0.9 cm^2 each, with six on the side with antioxidant preparation, and six on the side with control.
On Day 7±1, a visual assessment will be done of each exposed area, as well as quantitative colorimetric measurements and a research photograph. The visual assessment will consist in determination of the lowest fluence inducing visible pigmentation on each half back (with antioxidant and with control). The colorimetric measurements will be done on areas exposed to 320 and 640 J/cm^2 to compare the pigmentation present on skin to which antioxidant was applied and on skin to which control was applied. The colorimetric assessment of adjacent unexposed skin will also be performed. At Day 0, 1 and 7 visits, subjects will also be evaluated for adverse events.
- Conditions
- Pigmentation From Visible Light
- Being tested
- Vitamin E, Eucerin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Also called Antioxidant
EucerinDrug
Control
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant (LB) + control (UB) | Other | Antioxidant will be weighed and applied to an area on the lower back (LB) to be exposed with visible light at a concentration of 2 mg/cm^2. Control will also be weighed and applied to an area of the upper back (UB) to be exposed with visible light at a concentration of 2 mg/cm^2. These will be applied according to the randomization scheme. Receives: Drug: Vitamin E; Drug: Eucerin |
| Antioxidant (UB) and Control (LB) | Other | Antioxidant will be weighed and applied to an area on the upper back (UB) to be exposed with visible light at a concentration of 2 mg/cm^2. Control will also be weighed and applied to an area of the lower back (LB) to be exposed with visible light at a concentration of 2 mg/cm^2. These will be applied according to the randomization scheme. Receives: Drug: Vitamin E; Drug: Eucerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest mean fluence inducing visible pigmentation
Lowest mean fluence inducing visible pigmentation 7 days after visible light exposure for skin where a topical antioxidant was applied compared to skin where control was applied.
Measured: 7 days
Secondary outcomes (3)
Mean difference in pigmentation intensity
Difference in pigmentation intensity between skin with antioxidant and skin with control.
Measured: 7 days
Protection factor of antioxidant preparation against visible light
Protection factor of antioxidant preparation against visible light between antioxidant and control.
Measured: 7 days
Safety of the antioxidant preparation
Safety of the antioxidant preparation measured by the number of adverse events and the severity of adverse events compared to control
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pigmentation From Visible LightStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, FRCPC, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927679
- Sponsor's protocol ID
- Inno-6031
- Status last verified
- Mar 2014
- First submitted
- 20 Aug 2013
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahmoud BH, Ruvolo E, Hexsel CL, Liu Y, Owen MR, Kollias N, Lim HW, Hamzavi IH. Impact of long-wavelength UVA and visible light on melanocompetent skin. J Invest Dermatol. 2010 Aug;130(8):2092-7. doi: 10.1038/jid.2010.95. Epub 2010 Apr 22.
PubMed 20410914Sklar LR, Almutawa F, Lim HW, Hamzavi I. Effects of ultraviolet radiation, visible light, and infrared radiation on erythema and pigmentation: a review. Photochem Photobiol Sci. 2013 Jan;12(1):54-64. doi: 10.1039/c2pp25152c.
PubMed 23111621Lehmann P, Schwarz T. Photodermatoses: diagnosis and treatment. Dtsch Arztebl Int. 2011 Mar;108(9):135-41. doi: 10.3238/arztebl.2011.0135. Epub 2011 Mar 4.
PubMed 21442060Terezakis NK, Bazzano GS. Retinoids: compounds important to hair growth. Clin Dermatol. 1988 Oct-Dec;6(4):129-31. doi: 10.1016/0738-081x(88)90077-6.
PubMed 3063367Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
PubMed 3222167Pandya AG, Guevara IL. Disorders of hyperpigmentation. Dermatol Clin. 2000 Jan;18(1):91-8, ix. doi: 10.1016/s0733-8635(05)70150-9.
PubMed 10626115Liebel F, Kaur S, Ruvolo E, Kollias N, Southall MD. Irradiation of skin with visible light induces reactive oxygen species and matrix-degrading enzymes. J Invest Dermatol. 2012 Jul;132(7):1901-7. doi: 10.1038/jid.2011.476. Epub 2012 Feb 9.
PubMed 22318388Ball Arefiev KL, Hantash BM. Advances in the treatment of melasma: a review of the recent literature. Dermatol Surg. 2012 Jul;38(7 Pt 1):971-84. doi: 10.1111/j.1524-4725.2012.02435.x. Epub 2012 May 14.
PubMed 22583339Chen L, Hu JY, Wang SQ. The role of antioxidants in photoprotection: a critical review. J Am Acad Dermatol. 2012 Nov;67(5):1013-24. doi: 10.1016/j.jaad.2012.02.009. Epub 2012 Mar 9.
PubMed 22406231Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.
PubMed 21920241Kameyama K, Sakai C, Kondoh S, Yonemoto K, Nishiyama S, Tagawa M, Murata T, Ohnuma T, Quigley J, Dorsky A, Bucks D, Blanock K. Inhibitory effect of magnesium L-ascorbyl-2-phosphate (VC-PMG) on melanogenesis in vitro and in vivo. J Am Acad Dermatol. 1996 Jan;34(1):29-33. doi: 10.1016/s0190-9622(96)90830-0.
PubMed 8543691Ertam I, Mutlu B, Unal I, Alper S, Kivcak B, Ozer O. Efficiency of ellagic acid and arbutin in melasma: a randomized, prospective, open-label study. J Dermatol. 2008 Sep;35(9):570-4. doi: 10.1111/j.1346-8138.2008.00522.x.
PubMed 18837701Hwang SW, Oh DJ, Lee D, Kim JW, Park SW. Clinical efficacy of 25% L-ascorbic acid (C'ensil) in the treatment of melasma. J Cutan Med Surg. 2009 Mar-Apr;13(2):74-81. doi: 10.2310/7750.2008.07092.
PubMed 19298775Stella A, Golin R, Zanchetti A. Effects of reversible renal denervation on haemodynamic and excretory functions of the ipsilateral and contralateral kidney in the cat. J Hypertens. 1986 Apr;4(2):181-8. doi: 10.1097/00004872-198604000-00007.
PubMed 3519762Wu Y, Matsui MS, Chen JZ, Jin X, Shu CM, Jin GY, Dong GH, Wang YK, Gao XH, Chen HD, Li YH. Antioxidants add protection to a broad-spectrum sunscreen. Clin Exp Dermatol. 2011 Mar;36(2):178-87. doi: 10.1111/j.1365-2230.2010.03916.x. Epub 2010 Aug 27.
PubMed 20804506
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin E in the Prevention of Visible Light Induced Pigmentation
- ClinicalTrials.gov ID
- NCT01927679
- Acronym / sponsor ID
- Inno-6031
- Conditions
- Pigmentation From Visible Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Aug 2013 (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.
The main objective of the study is to assess the efficacy of an antioxidant in preventing pigmentation induced by visible light in subjects with a phototype IV or V.
Patients will be exposed to a range of visible light to areas on the back to confirm study eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible to continue.
Eligible patients will have study product applied to part of the back and placebo on another part of the back. The placebo area will be exposed to the same range of light based as at Day -7. The area where the antioxidant is applied will have a higher range of light exposure than the area without the study product.
Seven days later, the areas will be examined to determine the lowest exposure inducing pigmentation on the sides with placebo and with antioxidant. The color will also be measured between two identical exposures with placebo and with antioxidant.
Detailed description
At Day -7, all subjects will be exposed to a pre-specified range of doses of visible light on 6 areas of the back, each measuring 0.9 cm^2 in order to evaluate their pigmentary response to visible light. The doses will be 20, 40, 80, 160, 320 and 640 J/cm^2. At Day 0, a visual inspection will establish which subjects qualify for the remainder of the study, based on the presence or absence of pigmentation induced by visible light. Subjects who do not exhibit pigmentation at 640 J/cm^2 or lower will not pursue the study.
Subjects who demonstrate pigmentation will move on to the next step of the study. On this same Day 0 visit, these subjects will be randomized to receive a topical antioxidant preparation on one of two halves of their back and a control on the other side. The antioxidant and control will be applied twice before the exposure to visible light is done on Day 1: 24 hours prior (Day 0) and 30 minutes prior (Day 1) exposure. On Day 1, the skin with antioxidant will be exposed to fluences of 80, 160, 320, 640, 1280 and 1920 J/cm^2 whereas that with control will be exposed to the same lower doses as on Day -7. This will be done on a total of 12 different areas of 0.9 cm^2 each, with six on the side with antioxidant preparation, and six on the side with control.
On Day 7±1, a visual assessment will be done of each exposed area, as well as quantitative colorimetric measurements and a research photograph. The visual assessment will consist in determination of the lowest fluence inducing visible pigmentation on each half back (with antioxidant and with control). The colorimetric measurements will be done on areas exposed to 320 and 640 J/cm^2 to compare the pigmentation present on skin to which antioxidant was applied and on skin to which control was applied. The colorimetric assessment of adjacent unexposed skin will also be performed. At Day 0, 1 and 7 visits, subjects will also be evaluated for adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant (LB) + control (UB) | Other | Drug: Vitamin E, Drug: EucerinAntioxidant will be weighed and applied to an area on the lower back (LB) to be exposed with visible light at a concentration of 2 mg/cm^2. Control will also be weighed and applied to an area of the upper back (UB) to be exposed with visible light at a concentration of 2 mg/cm^2. These will be applied according to the randomization scheme. |
| Antioxidant (UB) and Control (LB) | Other | Drug: Vitamin E, Drug: EucerinAntioxidant will be weighed and applied to an area on the upper back (UB) to be exposed with visible light at a concentration of 2 mg/cm^2. Control will also be weighed and applied to an area of the lower back (LB) to be exposed with visible light at a concentration of 2 mg/cm^2. These will be applied according to the randomization scheme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men or women 18 years of age or older at time of consent.
- Subject, male or female, is willing to use effective contraceptive method for at least 30 days before Day -7 and at least until Day 7±1. Effective contraceptive methods are:
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
- Skin phototype IV and V
- Exhibits visible light-induced pigmentation at Day 0
Key exclusion criteria (10 listed)
- Current pregnancy or lactation
- Allergy to any of the products used in the study
- Use of phototherapy or tanning beds within the 30 days of the study start (Day -7)
- Use of photosensitizing medication within the 30 days or 5 half-lives (whichever is longest) from the study start (Day-7)
- Use of products other than the ones used in the study that may alter the pigmentation of the skin
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 |
|---|---|---|
| Vitamin EAlso: Antioxidant | Drug | Antioxidant (LB) + control (UB), Antioxidant (UB) and Control (LB) |
| EucerinControl | Drug | Antioxidant (LB) + control (UB), Antioxidant (UB) and Control (LB) |
Primary outcome
Lowest mean fluence inducing visible pigmentation
Time frame: 7 days
Lowest mean fluence inducing visible pigmentation 7 days after visible light exposure for skin where a topical antioxidant was applied compared to skin where control was applied.
3 secondary outcomes
Mean difference in pigmentation intensity
Time frame: 7 days
Protection factor of antioxidant preparation against visible light
Time frame: 7 days
Safety of the antioxidant preparation
Time frame: 7 days
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 4 Mar 2014.
- Background: PubMed 20410914Mahmoud BH, Ruvolo E, Hexsel CL, Liu Y, Owen MR, Kollias N, Lim HW, Hamzavi IH. Impact of long-wavelength UVA and visible light on melanocompetent skin. J Invest Dermatol. 2010 Aug;130(8):2092-7. doi: 10.1038/jid.2010.95. Epub 2010 Apr 22.
- Background: PubMed 23111621Sklar LR, Almutawa F, Lim HW, Hamzavi I. Effects of ultraviolet radiation, visible light, and infrared radiation on erythema and pigmentation: a review. Photochem Photobiol Sci. 2013 Jan;12(1):54-64. doi: 10.1039/c2pp25152c.
- Background: PubMed 21442060Lehmann P, Schwarz T. Photodermatoses: diagnosis and treatment. Dtsch Arztebl Int. 2011 Mar;108(9):135-41. doi: 10.3238/arztebl.2011.0135. Epub 2011 Mar 4.
- Background: PubMed 3063367Terezakis NK, Bazzano GS. Retinoids: compounds important to hair growth. Clin Dermatol. 1988 Oct-Dec;6(4):129-31. doi: 10.1016/0738-081x(88)90077-6.
- Background: PubMed 3222167Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
- Background: PubMed 10626115Pandya AG, Guevara IL. Disorders of hyperpigmentation. Dermatol Clin. 2000 Jan;18(1):91-8, ix. doi: 10.1016/s0733-8635(05)70150-9.
- Background: PubMed 22318388Liebel F, Kaur S, Ruvolo E, Kollias N, Southall MD. Irradiation of skin with visible light induces reactive oxygen species and matrix-degrading enzymes. J Invest Dermatol. 2012 Jul;132(7):1901-7. doi: 10.1038/jid.2011.476. Epub 2012 Feb 9.
- Background: PubMed 22583339Ball Arefiev KL, Hantash BM. Advances in the treatment of melasma: a review of the recent literature. Dermatol Surg. 2012 Jul;38(7 Pt 1):971-84. doi: 10.1111/j.1524-4725.2012.02435.x. Epub 2012 May 14.
- Background: PubMed 22406231Chen L, Hu JY, Wang SQ. The role of antioxidants in photoprotection: a critical review. J Am Acad Dermatol. 2012 Nov;67(5):1013-24. doi: 10.1016/j.jaad.2012.02.009. Epub 2012 Mar 9.
- Background: PubMed 21920241Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.
- Background: PubMed 8543691Kameyama K, Sakai C, Kondoh S, Yonemoto K, Nishiyama S, Tagawa M, Murata T, Ohnuma T, Quigley J, Dorsky A, Bucks D, Blanock K. Inhibitory effect of magnesium L-ascorbyl-2-phosphate (VC-PMG) on melanogenesis in vitro and in vivo. J Am Acad Dermatol. 1996 Jan;34(1):29-33. doi: 10.1016/s0190-9622(96)90830-0.
- Background: PubMed 18837701Ertam I, Mutlu B, Unal I, Alper S, Kivcak B, Ozer O. Efficiency of ellagic acid and arbutin in melasma: a randomized, prospective, open-label study. J Dermatol. 2008 Sep;35(9):570-4. doi: 10.1111/j.1346-8138.2008.00522.x.
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.
Robert Bissonnette, MD, FRCPC principal investigator
Innovaderm Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E and Eucerin in people with Pigmentation From Visible Light, run by Innovaderm Research Inc. at 1 site in Canada.
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 13 inclusion and 10 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 4 Mar 2014. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Lowest mean fluence inducing visible pigmentation (time frame: 7 days). 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 NCT01927679, which also lists 15 linked publications.
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 4 Mar 2014.