Periorbital HypermelanosisNCT04389788
Treatment of Patients With Periorbital Hyperpigmentation
A study testing carboxy therapy and Dermapen with topical glutathione in people with Periorbital Hypermelanosis, run by Sohag University at 1 site in Egypt.
Trial summary
Periorbital hyperpigmentation (POH) is a common condition in dermatology practice. Periorbital hyperpigmentation is defined as bilateral, round, homogeneous pigmented macules.The etiology of POH is multifactorial including genetic and enviromental factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Periorbital Hypermelanosis
- What is being tested?
- carboxy therapy and Dermapen with topical glutathione
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2020to 21 Oct 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Periorbital hyperpigmentation
Who cannot join
- Pregnancy and lactation .
- Allergy, hypersensitivity to the formulations to be used in the study.
- Any other cutaneous or systemic disease.
- Patient who had taken any other treatment (laser, dermabrasion) on the affected region performed less than 6 months prior to the beginning of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Combined Microneedling With Topical Glutathione Versus Carboxy Therapy in Treatment of Patients With Periorbital Hyperpigmentation
Periorbital hyperpigmentation (POH) is a common condition in dermatology practice. Periorbital hyperpigmentation is defined as bilateral, round, homogeneous pigmented macules.The etiology of POH is multifactorial including genetic and enviromental factors. Many treatment options are avaiblabe with variable efficacy and safety in different patients. Therefore, the investigator's study aims to evaluate the efficacy and safety of combined microneedling with topical Glutathione versus Carboxy Therapy in treatment of patients with periorbital hyperpigmentation.
Read the detailed description
Periorbital hyperpigmentation (POH) is a common skin condition which has a great negative effect on the patient quality of life. Many factors contribute in the pathogensis of POH which lead to developement of several treatment options with no treatment option has a great sucess in improving the POH and patient quality of life. Our current study tries to explore the efficacy and safety between 2 treatment methods in a split face study.
Microneedling is a process of making small punctres into the skin through small needles by device which is called a Dermapen. This microneedling method is beleived to be associated with improving the skin quality through increased collagen. This microneedling will be followed by topical application of glutathione which is a commong antioxidant with whitening effects.
Carboxy therapy is a new emerging treatment option in many dermatological diseases. It will be used in POH patients as it will be able to increase blood flow in periorbital area and improve the skin qulaity.
- Conditions
- Periorbital Hypermelanosis
- Being tested
- carboxy therapy, Dermapen with topical glutathione
- Keywords
- Periorbital hypermelanosis, Carboxy therapy, Microneedling, Topical Glutathione
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboxy therapyDevice
6 sessions of carboxy therapy every 2 weeks
Dermapen with topical glutathioneDevice
6 sessions of Dermapen microneedling with topical glutathione every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rt Eye | Active comparator | The right eye of the patients received carboxy therapy for 6 sessions every 2 weeks. The used device is locally manufactured by a national company for esthetic and dermatological devices. Carbon dioxide gas was subcutaneously injected at the lateral one-third of each eye lid (5 cc gas in each puff according to standardized flowmetry) using insulin syringe. Compression of the injected area will be avoided to prevent rapid leakage of the gas. Receives: Device: carboxy therapy |
| Lt Eye | Active comparator | The left eye of the same patients received microneedling with topical glutathione for 6 sessions every 2 weeks. Microneedling was done with Derma pen which is automatic and rechargeable device (vibrating frequency : 6500-10000 r/m , vibration speed level 5 , model :Ultima A6 , company : Dr ,pen and country : Korea). Needle length is adjustable from 0.25 mm to 0,5 mm.Needles number : 36 .Then, Patient was subjected to topical glutathione about 0.25 ml (vial : 600mg/5ml). Receives: Device: Dermapen with topical glutathione |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of periorbital hyperpigmentation through photo evaluation
High-resolution photographs of both sides of the face were taken. Using a physician visual analog scoring system, 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows 1 (worse), 2 (no change), 3 (<30%), 4 (30-60%), and 5 (>60%)
Measured: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Change of periorbital hyperpigmentation through dermoscopy evaluation
Dermoscopic evaluation was done using dermalite connection kit for Samsung galaxy. 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows
- Vasculature improvement (No 0, Yes 1) \& percent of improvement.
- Pigmentation improvement (No 0, Yes 1) \& percent of improvement.
- Skin improvement like atrophy and exaggerated skin markings (No 0, Yes 1) \& percent of improvement.
Measured: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Change of the patient satisfaction evaluation: scale
The patients were asked to evaluate their own level of satisfaction after they completed the study on a 1-3 scale: 1 = slightly satisfied, 2 = moderately satisfied, and 3 = well satisfied
Measured: Baseline and 1 month after end of treatment
Change of periorbital hyperpigmentation into another skin problem through safety evaluation
Safety evaluation to detect precentage of side effects reported either by the patient or by the physician.
Measured: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Secondary outcomes (1)
The Dermatology Life Quality Index questionnaire
The Dermatology Life Quality Index questionnaire (DLQI) is 10 questions were asked to the patients and score is 0-3 for each question. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline, before 3rd session, before 5th session,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start12 Feb 2020
- Primary completion10 Oct 2020
- Study completion21 Oct 2020
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 Periorbital HypermelanosisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients with periorbital hyperpigmentation will be treated using Carboxy theraby method at right side of face followed by microneedling using dermapen will be at left side of face.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelhamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389788
- Sponsor's protocol ID
- Sohagu309
- Status last verified
- Oct 2020
- First submitted
- 4 May 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Assaf HA, Ahmed D, Abdelhamed A. Efficacy and Safety of Carboxytherapy versus Combined Microneedling with Topical Glutathione in the Treatment of Patients with Periorbital Hyperpigmentation: An Evaluator-Blind, Split-Face, Controlled Pilot Clinical Trial. Indian J Dermatol. 2022 Sep-Oct;67(5):504-511. doi: 10.4103/ijd.ijd_394_21.
PubMed 36865870
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combined Microneedling With Topical Glutathione Versus Carboxy Therapy in Treatment of Patients With Periorbital Hyperpigmentation
- ClinicalTrials.gov ID
- NCT04389788
- Acronym / sponsor ID
- Sohagu309
- Conditions
- Periorbital Hypermelanosis
- Keywords
- Periorbital hypermelanosis, Carboxy therapy, Microneedling, Topical Glutathione
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 15 May 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.
Periorbital hyperpigmentation (POH) is a common condition in dermatology practice. Periorbital hyperpigmentation is defined as bilateral, round, homogeneous pigmented macules.The etiology of POH is multifactorial including genetic and enviromental factors. Many treatment options are avaiblabe with variable efficacy and safety in different patients. Therefore, the investigator's study aims to evaluate the efficacy and safety of combined microneedling with topical Glutathione versus Carboxy Therapy in treatment of patients with periorbital hyperpigmentation.
Detailed description
Periorbital hyperpigmentation (POH) is a common skin condition which has a great negative effect on the patient quality of life. Many factors contribute in the pathogensis of POH which lead to developement of several treatment options with no treatment option has a great sucess in improving the POH and patient quality of life. Our current study tries to explore the efficacy and safety between 2 treatment methods in a split face study.
Microneedling is a process of making small punctres into the skin through small needles by device which is called a Dermapen. This microneedling method is beleived to be associated with improving the skin quality through increased collagen. This microneedling will be followed by topical application of glutathione which is a commong antioxidant with whitening effects.
Carboxy therapy is a new emerging treatment option in many dermatological diseases. It will be used in POH patients as it will be able to increase blood flow in periorbital area and improve the skin qulaity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with periorbital hyperpigmentation will be treated using Carboxy theraby method at right side of face followed by microneedling using dermapen will be at left side of face.
| Arm | Type | Receives |
|---|---|---|
| Rt Eye | Active comparator | Device: carboxy therapyThe right eye of the patients received carboxy therapy for 6 sessions every 2 weeks. The used device is locally manufactured by a national company for esthetic and dermatological devices. Carbon dioxide gas was subcutaneously injected at the lateral one-third of each eye lid (5 cc gas in each puff according to standardized flowmetry) using insulin syringe. Compression of the injected area will be avoided to prevent rapid leakage of the gas. |
| Lt Eye | Active comparator | Device: Dermapen with topical glutathioneThe left eye of the same patients received microneedling with topical glutathione for 6 sessions every 2 weeks. Microneedling was done with Derma pen which is automatic and rechargeable device (vibrating frequency : 6500-10000 r/m , vibration speed level 5 , model :Ultima A6 , company : Dr ,pen and country : Korea). Needle length is adjustable from 0.25 mm to 0,5 mm.Needles number : 36 .Then, Patient was subjected to topical glutathione about 0.25 ml (vial : 600mg/5ml). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Periorbital hyperpigmentation
Key exclusion criteria (4 listed)
- Pregnancy and lactation .
- Allergy, hypersensitivity to the formulations to be used in the study.
- Any other cutaneous or systemic disease.
- Patient who had taken any other treatment (laser, dermabrasion) on the affected region performed less than 6 months prior to the beginning of the study.
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 |
|---|---|---|
| carboxy therapy6 sessions of carboxy therapy every 2 weeks | Device | Rt Eye |
| Dermapen with topical glutathione6 sessions of Dermapen microneedling with topical glutathione every 2 weeks | Device | Lt Eye |
Primary outcome
Change of periorbital hyperpigmentation through photo evaluation
Time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
High-resolution photographs of both sides of the face were taken. Using a physician visual analog scoring system, 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows 1 (worse), 2 (no change), 3 (<30%), 4 (30-60%), and 5 (>60%)
Change of periorbital hyperpigmentation through dermoscopy evaluation
Time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Dermoscopic evaluation was done using dermalite connection kit for Samsung galaxy. 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows * Vasculature improvement (No 0, Yes 1) \& percent of improvement. * Pigmentation improvement (No 0, Yes 1) \& percent of improvement. * Skin improvement like atrophy and exaggerated skin markings (No 0, Yes 1) \& percent of improvement.
Change of the patient satisfaction evaluation: scale
Time frame: Baseline and 1 month after end of treatment
The patients were asked to evaluate their own level of satisfaction after they completed the study on a 1-3 scale: 1 = slightly satisfied, 2 = moderately satisfied, and 3 = well satisfied
Change of periorbital hyperpigmentation into another skin problem through safety evaluation
Time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Safety evaluation to detect precentage of side effects reported either by the patient or by the physician.
1 secondary outcome
The Dermatology Life Quality Index questionnaire
Time frame: Baseline, before 3rd session, before 5th session,
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 23 Oct 2020.
- Derived from this study: PubMed 36865870Assaf HA, Ahmed D, Abdelhamed A. Efficacy and Safety of Carboxytherapy versus Combined Microneedling with Topical Glutathione in the Treatment of Patients with Periorbital Hyperpigmentation: An Evaluator-Blind, Split-Face, Controlled Pilot Clinical Trial. Indian J Dermatol. 2022 Sep-Oct;67(5):504-511. doi: 10.4103/ijd.ijd_394_21.
- Individual participant dataSharing planned: Yes
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 study testing carboxy therapy and Dermapen with topical glutathione in people with Periorbital Hypermelanosis, run by Sohag 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 1 inclusion and 4 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 23 Oct 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?
Change of periorbital hyperpigmentation through photo evaluation (time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment). The study lists 4 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 NCT04389788, 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 23 Oct 2020.