Clinical TrialID 5645
Treatment of Patients With Periorbital Hyperpigmentation
NCT04389788
Periorbital Hypermelanosis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5645
- Evidence Id
- 5645
- Core Evidence Id
- 5645
- Source Clinical Trial Id
- 5630
- Herb2 Clinical Trial Id
- HBCT005630
- Nct Id
- NCT04389788
- Title
- Treatment of Patients With Periorbital Hyperpigmentation
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Periorbital Hypermelanosis
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DEVICE: carboxy therapy|DEVICE: Dermapen with topical glutathione
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Adult, Older_Adult
- Enrollment
- 31
- Outcome Measure
- 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%), 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., 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, 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., Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
- Sponsor Collaborator
- Sohag University
- Funded By
- OTHER
- Location
- Faculty of Medicine, Sohag University, Sohag, 82524, Egypt
- Other Id
- Sohagu309
- Start Date
- 2020-02-12
- Primary Completion Date
- 2020-10-10
- Completion Date
- 2020-10-21
- First Posted
- 2020-05-15
- Results First Posted
- Last Update Posted
- 2020-10-23
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04389788
- Title Cn
- Title En
- Treatment of Patients With Periorbital Hyperpigmentation
- Bilingual Status
- semi_complete