Acquired HypomelanosisNCT04419350
Microneedling for Acquired Hypomelanosis
A study testing Microneedling in people with Acquired Hypomelanosis, run by Cairo University at 1 site in Egypt.
Trial summary
Acquired hypomelanosis is a type of cutaneous melanocytopenic hypomelanosis, denoting the lightening of the skin due to a reduction in the number of epidermal and/or follicular melanocytes secondary to physical agents,post-inflammatory, and iatrogenic (steroids). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Hypomelanosis
- What is being tested?
- Microneedling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2019to 1 May 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localized acquired hypomelanosis secondary to any insult, post-inflammatory or iatrogenic of no more than 2 years duration, affecting any anatomical site except genitalia, of any size larger than 3 cm in diameter.
- Patients older than 18 years old, consenting to go through the microneedling procedure.
- Both genders.
Who cannot join
- Congenital and hereditary hypomelanosis.
- Vitiligo
- Pregnancy and lactation.
- Patients with history of any autoimmune disease.
- Patients with history of keloids formation.
- Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial
Acquired hypomelanosis is a type of cutaneous melanocytopenic hypomelanosis, denoting the lightening of the skin due to a reduction in the number of epidermal and/or follicular melanocytes secondary to physical agents,post-inflammatory, and iatrogenic (steroids).
Derma roller is the basic device of microneedling , performs superficial, controlled puncturing of the skin by rolling with miniature fine needles and used as a collagen induction therapy and a transdermal delivery system for therapeutic drugs and vaccines.
This minute trauma to the skin that activates regenerative mechanisms and wound healing by releasing growth factors. The release of cytokines and deposition of hemosiderin from dermal bleeding induce the activation of melanocyte and stimulate skin pigmentation plus transdermal traveling of melanocyte
Read the detailed description
The aim of this study to evaluate the efficacy and safety of microneedling as a treatment model for patients with acquired hypomelanosis.
Patients with an acquired hypomelanosis from outpatient clinic, department of dermatology, Cairo university,n=20. including:
▪Patients, both genders and older than 18 years with localized acquired hypomelanosis
Excluding:
- Congenital and hereditary hypomelanosis.
- Vitiligo
- Pregnancy and lactation.
- Patients with a history of any autoimmune disease.
- Patients with a history of keloid formation.
- Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.
Methodology in details:
- An informed written consent will be obtained from the patient or his legal guardian if he is younger than 21years old.
- For every patient detailed history will focus on the onset, course, duration of hypomelanosis, the type of insult, previous treatments, systemic illness and drug history. The examination will describe the anatomical site, size, degree of skin lightening, skin texture and presence or absence of hair in the affected area.
- The area to be treated will be specified and split into two halves then randomized into one of both arms: treatment or no treatment.
- One session of microneedling will be performed on the treatment arm by using dermaroller 1.5 mm long. The microneedling will be done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).
- Patients will be then monitored for three months for signs of repigmentation.
- Patient's improvement will be objectively assessed monthly for repigmentation using patient's and physician's scales.
Possible Risk:
Pain, transient bleeding, erythema, mild edema and infection at the site of microneedling. Failure of treatment is also a possibility.
Primary outcomes:
Efficacy of microneedling for acquired hypomelanosis after 3 months.
Secondary outcome:
Safety as defined by the occurrence of adverse events during, shortly after the procedure (2weeks), and after 3 months.
Sample size(number of patients included):20 patients
Source of funding: self funding
- Conditions
- Acquired Hypomelanosis
- Being tested
- Microneedling
- Keywords
- Microneedling, Dermaroller, acquired hypomelanosis, skin pigmentation, hypopigmentation, patient satisfaction, leukoderma
- Medical subject headings
- Pigmentation Disorders, Hypopigmentation, Patient Satisfaction, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingProcedure or surgery
One session of microneedling will be performed by using dermaroller 1.5 mm. The microneedling done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | microneedling. Receives: Procedure: Microneedling |
| No treatment | No intervention | No treatment will be done to these hypopigmented lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning.
drawing the lesion's surface area through transparent stencil paper
Measured: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning
using hue skin tone color scale
Measured: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation.
The repigmentation assessed by percentage value range from 0- 100% where the 100 % means full repigmentation, the value is a result of an equation where the estimated percentage of marginal repigmentation add to ( remaining area (%) plus estimated percent of perifollicular pigmentation in the remaining area(%) divided by 100)
Measured: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score
3-point scale (not satisfied, moderately satisfied, extremely satisfied).
Measured: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%).
the patient evaluation to lesion by percentage value for repigmentation ranged from 0- 100% which represent full repigmentation.
Measured: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%).
One unblinded and 2 blinded investigators assessed the global improvement through photographs of the lesions before and after 3 months of therapy. The lesions were photographed on a black background using a single reflex camera with standardized settings (ambient light, same position, and distance from the patient).
Measured: 3 moonths post treatment.
Secondary outcomes (1)
Incidence of microneedling adverse events
Safety as defined by occurrence of pain, bleeding, local infection, skin flaking, and scarring during, shortly after the procedure (2weeks), and at the end of the study.
Measured: Day 1 to 14 and after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Sep 2019
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Acquired HypomelanosisStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * The area to be treated will be specified and split into two halves then randomized using sealed envelope into one of both arms: treatment or no treatment. * One session of microneedling using derma roller 1.5 mm will be done.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julbahar Ibrahim, Cairo University
- Investigators
- Khaled H El-Hoshy, MD, Principal investigator, Professor of Dermatology,Cairo UniversityVanessa G Hafez, MD, Principal investigator, Associate Professor of Dermatology, Cairo UniversityJulbahar M Ibrahim, M.B.,B.CH, Principal investigator, Dermatology Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419350
- Sponsor's protocol ID
- MN for acquired hypomelanosis
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeitlin RE. Long-term psychosocial sequelae of paediatric burns. Burns. 1997 Sep;23(6):467-72. doi: 10.1016/s0305-4179(97)00045-4.
PubMed 9429023Tyack ZF, Pegg S, Ziviani J. Postburn dyspigmentation: its assessment, management, and relationship to scarring--a review of the literature. J Burn Care Rehabil. 1997 Sep-Oct;18(5):435-40. doi: 10.1097/00004630-199709000-00012.
PubMed 9313126Sperry K. Tattoos and tattooing. Part I: History and methodology. Am J Forensic Med Pathol. 1991 Dec;12(4):313-9. doi: 10.1097/00000433-199112000-00008.
PubMed 1807141Singh A, Yadav S. Microneedling: Advances and widening horizons. Indian Dermatol Online J. 2016 Jul-Aug;7(4):244-54. doi: 10.4103/2229-5178.185468.
PubMed 27559496Siadat AH, Rezaei R, Asilian A, Abtahi-Naeini B, Rakhshanpour M, Raei M, Hosseini SM. Repigmentation of Hypopigmented Scars Using Combination of Fractionated Carbon Dioxide Laser with Topical Latanoprost Vs. Fractionated Carbon Dioxide Laser Alone. Indian J Dermatol. 2015 Jul-Aug;60(4):364-8. doi: 10.4103/0019-5154.160481.
PubMed 26288404Kahn AM, Cohen MJ. Treatment for depigmentation following burn injuries. Burns. 1996 Nov;22(7):552-4. doi: 10.1016/0305-4179(96)88885-1.
PubMed 8909758Imokawa G. Autocrine and paracrine regulation of melanocytes in human skin and in pigmentary disorders. Pigment Cell Res. 2004 Apr;17(2):96-110. doi: 10.1111/j.1600-0749.2003.00126.x.
PubMed 15016298Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.
PubMed 27755171Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4. doi: 10.1111/j.1524-4725.2007.33058.x.
PubMed 17338685Cho S, Zheng Z, Park YK, Roh MR. The 308-nm excimer laser: a promising device for the treatment of childhood vitiligo. Photodermatol Photoimmunol Photomed. 2011 Feb;27(1):24-9. doi: 10.1111/j.1600-0781.2010.00558.x.
PubMed 21198879Chadwick S, Heath R, Shah M. Abnormal pigmentation within cutaneous scars: A complication of wound healing. Indian J Plast Surg. 2012 May;45(2):403-11. doi: 10.4103/0970-0358.101328.
PubMed 23162241Busch KH, Bender R, Walezko N, Aziz H, Altintas MA, Aust MC. Combination of medical needling and non-cultured autologous skin cell transplantation (ReNovaCell) for repigmentation of hypopigmented burn scars. Burns. 2016 Nov;42(7):1556-1566. doi: 10.1016/j.burns.2016.04.009. Epub 2016 May 4.
PubMed 27156803Busch KH, Bender R, Walezko N, Aziz H, Altintas MA, Aust MC. Combination of medical needling and non-cultured autologous skin cell transplantation (renovacell) for repigmentation of hypopigmented burn scars in children and young people. Ann Burns Fire Disasters. 2016 Jun 30;29(2):116-122.
PubMed 28149233Aust MC, Fernandes D, Kolokythas P, Kaplan HM, Vogt PM. Percutaneous collagen induction therapy: an alternative treatment for scars, wrinkles, and skin laxity. Plast Reconstr Surg. 2008 Apr;121(4):1421-1429. doi: 10.1097/01.prs.0000304612.72899.02.
PubMed 18349665Alexiades-Armenakas MR, Bernstein LJ, Friedman PM, Geronemus RG. The safety and efficacy of the 308-nm excimer laser for pigment correction of hypopigmented scars and striae alba. Arch Dermatol. 2004 Aug;140(8):955-60. doi: 10.1001/archderm.140.8.955.
PubMed 15313811
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04419350
- Acronym / sponsor ID
- MN for acquired hypomelanosis
- Conditions
- Acquired Hypomelanosis
- Keywords
- Microneedling, Dermaroller, acquired hypomelanosis, skin pigmentation, hypopigmentation, patient satisfaction, leukoderma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 5 Jun 2020 (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.
Acquired hypomelanosis is a type of cutaneous melanocytopenic hypomelanosis, denoting the lightening of the skin due to a reduction in the number of epidermal and/or follicular melanocytes secondary to physical agents,post-inflammatory, and iatrogenic (steroids).
Derma roller is the basic device of microneedling , performs superficial, controlled puncturing of the skin by rolling with miniature fine needles and used as a collagen induction therapy and a transdermal delivery system for therapeutic drugs and vaccines.
This minute trauma to the skin that activates regenerative mechanisms and wound healing by releasing growth factors. The release of cytokines and deposition of hemosiderin from dermal bleeding induce the activation of melanocyte and stimulate skin pigmentation plus transdermal traveling of melanocyte
Detailed description
The aim of this study to evaluate the efficacy and safety of microneedling as a treatment model for patients with acquired hypomelanosis.
Patients with an acquired hypomelanosis from outpatient clinic, department of dermatology, Cairo university,n=20. including:
▪Patients, both genders and older than 18 years with localized acquired hypomelanosis
Excluding:
- Congenital and hereditary hypomelanosis.
- Vitiligo
- Pregnancy and lactation.
- Patients with a history of any autoimmune disease.
- Patients with a history of keloid formation.
- Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.
Methodology in details:
- An informed written consent will be obtained from the patient or his legal guardian if he is younger than 21years old.
- For every patient detailed history will focus on the onset, course, duration of hypomelanosis, the type of insult, previous treatments, systemic illness and drug history. The examination will describe the anatomical site, size, degree of skin lightening, skin texture and presence or absence of hair in the affected area.
- The area to be treated will be specified and split into two halves then randomized into one of both arms: treatment or no treatment.
- One session of microneedling will be performed on the treatment arm by using dermaroller 1.5 mm long. The microneedling will be done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).
- Patients will be then monitored for three months for signs of repigmentation.
- Patient's improvement will be objectively assessed monthly for repigmentation using patient's and physician's scales.
Possible Risk:
Pain, transient bleeding, erythema, mild edema and infection at the site of microneedling. Failure of treatment is also a possibility.
Primary outcomes:
Efficacy of microneedling for acquired hypomelanosis after 3 months.
Secondary outcome:
Safety as defined by the occurrence of adverse events during, shortly after the procedure (2weeks), and after 3 months.
Sample size(number of patients included):20 patients
Source of funding: self funding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * The area to be treated will be specified and split into two halves then randomized using sealed envelope into one of both arms: treatment or no treatment. * One session of microneedling using derma roller 1.5 mm will be done.
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Procedure: Microneedlingmicroneedling. |
| No treatment | No intervention | –No treatment will be done to these hypopigmented lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Localized acquired hypomelanosis secondary to any insult, post-inflammatory or iatrogenic of no more than 2 years duration, affecting any anatomical site except genitalia, of any size larger than 3 cm in diameter.
- Patients older than 18 years old, consenting to go through the microneedling procedure.
- Both genders.
Key exclusion criteria (6 listed)
- Congenital and hereditary hypomelanosis.
- Vitiligo
- Pregnancy and lactation.
- Patients with history of any autoimmune disease.
- Patients with history of keloids formation.
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 |
|---|---|---|
| MicroneedlingOne session of microneedling will be performed by using dermaroller 1.5 mm. The microneedling done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal). | Procedure or surgery | treatment |
Primary outcome
Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning.
Time frame: 3 months post treatment
drawing the lesion's surface area through transparent stencil paper
Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning
Time frame: 3 months post treatment
using hue skin tone color scale
Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation.
Time frame: 3 months post treatment
The repigmentation assessed by percentage value range from 0- 100% where the 100 % means full repigmentation, the value is a result of an equation where the estimated percentage of marginal repigmentation add to ( remaining area (%) plus estimated percent of perifollicular pigmentation in the remaining area(%) divided by 100)
Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score
Time frame: 3 months post treatment
3-point scale (not satisfied, moderately satisfied, extremely satisfied).
Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%).
Time frame: 3 months post treatment
the patient evaluation to lesion by percentage value for repigmentation ranged from 0- 100% which represent full repigmentation.
Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%).
Time frame: 3 moonths post treatment.
One unblinded and 2 blinded investigators assessed the global improvement through photographs of the lesions before and after 3 months of therapy. The lesions were photographed on a black background using a single reflex camera with standardized settings (ambient light, same position, and distance from the patient).
1 secondary outcome
Incidence of microneedling adverse events
Time frame: Day 1 to 14 and after 3 months.
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 9 Jun 2020.
- Background: PubMed 9429023Zeitlin RE. Long-term psychosocial sequelae of paediatric burns. Burns. 1997 Sep;23(6):467-72. doi: 10.1016/s0305-4179(97)00045-4.
- Background: PubMed 9313126Tyack ZF, Pegg S, Ziviani J. Postburn dyspigmentation: its assessment, management, and relationship to scarring--a review of the literature. J Burn Care Rehabil. 1997 Sep-Oct;18(5):435-40. doi: 10.1097/00004630-199709000-00012.
- Background: PubMed 1807141Sperry K. Tattoos and tattooing. Part I: History and methodology. Am J Forensic Med Pathol. 1991 Dec;12(4):313-9. doi: 10.1097/00000433-199112000-00008.
- Background: PubMed 27559496Singh A, Yadav S. Microneedling: Advances and widening horizons. Indian Dermatol Online J. 2016 Jul-Aug;7(4):244-54. doi: 10.4103/2229-5178.185468.
- Background: PubMed 26288404Siadat AH, Rezaei R, Asilian A, Abtahi-Naeini B, Rakhshanpour M, Raei M, Hosseini SM. Repigmentation of Hypopigmented Scars Using Combination of Fractionated Carbon Dioxide Laser with Topical Latanoprost Vs. Fractionated Carbon Dioxide Laser Alone. Indian J Dermatol. 2015 Jul-Aug;60(4):364-8. doi: 10.4103/0019-5154.160481.
- Background: PubMed 8909758Kahn AM, Cohen MJ. Treatment for depigmentation following burn injuries. Burns. 1996 Nov;22(7):552-4. doi: 10.1016/0305-4179(96)88885-1.
- Background: PubMed 15016298Imokawa G. Autocrine and paracrine regulation of melanocytes in human skin and in pigmentary disorders. Pigment Cell Res. 2004 Apr;17(2):96-110. doi: 10.1111/j.1600-0749.2003.00126.x.
- Background: PubMed 27755171Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.
- Background: PubMed 17338685Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4. doi: 10.1111/j.1524-4725.2007.33058.x.
- Background: PubMed 21198879Cho S, Zheng Z, Park YK, Roh MR. The 308-nm excimer laser: a promising device for the treatment of childhood vitiligo. Photodermatol Photoimmunol Photomed. 2011 Feb;27(1):24-9. doi: 10.1111/j.1600-0781.2010.00558.x.
- Background: PubMed 23162241Chadwick S, Heath R, Shah M. Abnormal pigmentation within cutaneous scars: A complication of wound healing. Indian J Plast Surg. 2012 May;45(2):403-11. doi: 10.4103/0970-0358.101328.
- Background: PubMed 27156803Busch KH, Bender R, Walezko N, Aziz H, Altintas MA, Aust MC. Combination of medical needling and non-cultured autologous skin cell transplantation (ReNovaCell) for repigmentation of hypopigmented burn scars. Burns. 2016 Nov;42(7):1556-1566. doi: 10.1016/j.burns.2016.04.009. Epub 2016 May 4.
- 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.
Khaled H El-Hoshy, MD principal investigator
Professor of Dermatology,Cairo University
Vanessa G Hafez, MD principal investigator
Associate Professor of Dermatology, Cairo University
Julbahar M Ibrahim, M.B.,B.CH principal investigator
Dermatology Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling in people with Acquired Hypomelanosis, run by Cairo University at 1 site in Egypt.
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 9 Jun 2020. 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 Egypt. 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?
Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning. (time frame: 3 months post treatment). The study lists 6 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 NCT04419350, which also lists 17 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 9 Jun 2020.