MelasmaPhase 1NCT06201624
Oral Isotretinoin in Melasma a Randomized Controlled Trial
A Phase 1 study testing Isotretinoin and Triple combination formula in people with Melasma, run by Zagazig University at 1 site in Egypt.
Trial summary
Melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. Melasma is challenging to treat. Treatment is often a multimodality approach. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Melasma
- What is being tested?
- Isotretinoin and Triple combination formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 31 May 2024
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- Patients complaining of melasma.
- Patients with all types of melasma (epidermal, dermal and mixed)
- Sexually active women who is willing to follow at least 2 types of contraceptive methods during study period
- Patients with skin type I-V
Who cannot join
- Pregnant or nursing women.
- Women on any concurrent therapy for melasma.
- Patients that are using any therapy for melasma for the last 45 days.
- Patient with abnormal liver function test or lipid profile.
- Patients with allergy or hypersensitivity to the assigned drugs.
- Women not willing to follow contraceptive methods at time of study.
Show all 9Show fewer
- Patients on facial treatments or photosensitizing drugs within previous 6 months.
- Patients with back or joint pain.
- Patients with pre-existing or dormant dermatologic disease on the face that could interfere with the outcome of the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
Zagazig, Select Region, 44511
Hagar Nofal, Dr., 01006387707, hagarnofal@aucegypt.edu
About this study
Official title: Oral Isotretinoin in The Treatment of Melasma A Randomized Controlled Clinical Trial
Melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. Melasma is challenging to treat. Treatment is often a multimodality approach. Due to the attached psychological and social stress, it is important to counsel patients with melasma adequately about the chronicity of the disease, the importance of photoprotection, and the role of hormones in disease persistence before embarking on therapeutic correction. So in this study, we are exploring the efficacy of oral isotretinoin for treating melasma.
Read the detailed description
Melasma has a significant impact on the quality of life and self-esteem of those affected. Darker skin photo types e.g. Egyptians have excess potential to develop melasma.
Melasma is a chronic and challenging condition to manage. Previous treatment modalities have been unsatisfactory.
Oral isotretinoin is a potential treatment modality for melasma that has not been investigated yet.
In this study we aim to evaluate the efficacy and the tolerability of oral isotretinoin in the treatment of melasma and to compare its efficacy and tolerability with the current gold standard "topical triple combination formula"
- Conditions
- Melasma
- Being tested
- Isotretinoin, Triple combination formula
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Patients will receive 1mg/kg/day for 3 months
Triple combination formulaDrug
Also called modified Kligman formula
Patients are instructed to apply the triple combination formula at night daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin | Experimental | patients will receive oral isotretinoin (1 mg/kg/day) for 3 months Receives: Drug: Isotretinoin |
| Kligman Formula arm | Active comparator | patients will receive topical triple combination formula at night everyday over the affected areas for 3 months Receives: Drug: Triple combination formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Treatment efficacy will be assessed by the change in disease severity measured in mMASI at the end of the treatment period, and the difference in the global appearance of melasma through standardized photographs using Global Aesthetic Improvement Scale (GAIS) using a five-point ordinal scale (1 = exceptionally improved appearance, 2 = very improved appearance, 3 = improved appearance, 4 = unaltered appearance, 5 = worsened appearance). The duration taken till complete clearance will be assessed as well.
Measured: three months
Time to complete clearance
The duration taken till complete clearance will be assessed as well.
Measured: 12 weeks
Secondary outcomes (2)
Quality of life index
The change in patients' quality of life using the difference between results of "Melasma Quality of Life Index" at baseline and end of treatment.
Measured: 12 weeks
Treatment tolerability
Treatment tolerability will be assessed in terms of the side effects reported by the investigator or the patients in follow-up visits including but not limited to; facial erythema, scaling, a burning sensation, and cheilitis. Patients' compliance assessed by the percentage of patients withdraw from each arm of the study and the number of days per week the patients' take/apply their medication.
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 posted11 Jan 2024
- Study start1 Mar 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Zagazig 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hagar Nofal, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201624
- Sponsor's protocol ID
- ZU-IRB#10462/26-2-2023
- Status last verified
- Dec 2023
- First submitted
- 30 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and a copy of the master sheet for data collection, the statistical analysis plan will be shared and the results will be published in a respective journal
Publications
Artzi O, Horovitz T, Bar-Ilan E, Shehadeh W, Koren A, Zusmanovitch L, Mehrabi JN, Salameh F, Isman Nelkenbaum G, Zur E, Sprecher E, Mashiah J. The pathogenesis of melasma and implications for treatment. J Cosmet Dermatol. 2021 Nov;20(11):3432-3445. doi: 10.1111/jocd.14382. Epub 2021 Aug 19.
PubMed 34411403Garner ML, McShane DB, Burkhart CN, Morrell DS. Isotretinoin and vitiligo: can chronic cheilitis cause koebnerization? Pediatr Dermatol. 2015 May-Jun;32(3):e108-9. doi: 10.1111/pde.12538. Epub 2015 Mar 17.
PubMed 25781892Muthu SK, Narang T, Saikia UN, Kanwar AJ, Parsad D, Dogra S. Low-dose oral isotretinoin therapy in lichen planus pigmentosus: an open-label non-randomized prospective pilot study. Int J Dermatol. 2016 Sep;55(9):1048-54. doi: 10.1111/ijd.13293. Epub 2016 Apr 7.
PubMed 27062273
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Isotretinoin in The Treatment of Melasma A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06201624
- Acronym / sponsor ID
- ZU-IRB#10462/26-2-2023
- Conditions
- Melasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
Melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. Melasma is challenging to treat. Treatment is often a multimodality approach. Due to the attached psychological and social stress, it is important to counsel patients with melasma adequately about the chronicity of the disease, the importance of photoprotection, and the role of hormones in disease persistence before embarking on therapeutic correction. So in this study, we are exploring the efficacy of oral isotretinoin for treating melasma.
Detailed description
Melasma has a significant impact on the quality of life and self-esteem of those affected. Darker skin photo types e.g. Egyptians have excess potential to develop melasma.
Melasma is a chronic and challenging condition to manage. Previous treatment modalities have been unsatisfactory.
Oral isotretinoin is a potential treatment modality for melasma that has not been investigated yet.
In this study we aim to evaluate the efficacy and the tolerability of oral isotretinoin in the treatment of melasma and to compare its efficacy and tolerability with the current gold standard "topical triple combination formula"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin | Experimental | Drug: Isotretinoinpatients will receive oral isotretinoin (1 mg/kg/day) for 3 months |
| Kligman Formula arm | Active comparator | Drug: Triple combination formulapatients will receive topical triple combination formula at night everyday over the affected areas for 3 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 50 years
- Patients complaining of melasma.
- Patients with all types of melasma (epidermal, dermal and mixed)
- Sexually active women who is willing to follow at least 2 types of contraceptive methods during study period
- Patients with skin type I-V
Key exclusion criteria (9 listed)
- Pregnant or nursing women.
- Women on any concurrent therapy for melasma.
- Patients that are using any therapy for melasma for the last 45 days.
- Patient with abnormal liver function test or lipid profile.
- Patients with allergy or hypersensitivity to the assigned drugs.
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 |
|---|---|---|
| IsotretinoinPatients will receive 1mg/kg/day for 3 months | Drug | Isotretinoin |
| Triple combination formulaAlso: modified Kligman formulaPatients are instructed to apply the triple combination formula at night daily for 3 months | Drug | Kligman Formula arm |
Primary outcome
Response to treatment
Time frame: three months
Treatment efficacy will be assessed by the change in disease severity measured in mMASI at the end of the treatment period, and the difference in the global appearance of melasma through standardized photographs using Global Aesthetic Improvement Scale (GAIS) using a five-point ordinal scale (1 = exceptionally improved appearance, 2 = very improved appearance, 3 = improved appearance, 4 = unaltered appearance, 5 = worsened appearance). The duration taken till complete clearance will be assessed as well.
Time to complete clearance
Time frame: 12 weeks
The duration taken till complete clearance will be assessed as well.
2 secondary outcomes
Quality of life index
Time frame: 12 weeks
Treatment tolerability
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 34411403Artzi O, Horovitz T, Bar-Ilan E, Shehadeh W, Koren A, Zusmanovitch L, Mehrabi JN, Salameh F, Isman Nelkenbaum G, Zur E, Sprecher E, Mashiah J. The pathogenesis of melasma and implications for treatment. J Cosmet Dermatol. 2021 Nov;20(11):3432-3445. doi: 10.1111/jocd.14382. Epub 2021 Aug 19.
- Background: PubMed 25781892Garner ML, McShane DB, Burkhart CN, Morrell DS. Isotretinoin and vitiligo: can chronic cheilitis cause koebnerization? Pediatr Dermatol. 2015 May-Jun;32(3):e108-9. doi: 10.1111/pde.12538. Epub 2015 Mar 17.
- Background: PubMed 27062273Muthu SK, Narang T, Saikia UN, Kanwar AJ, Parsad D, Dogra S. Low-dose oral isotretinoin therapy in lichen planus pigmentosus: an open-label non-randomized prospective pilot study. Int J Dermatol. 2016 Sep;55(9):1048-54. doi: 10.1111/ijd.13293. Epub 2016 Apr 7.
- Individual participant dataSharing planned: Yes. The study protocol and a copy of the master sheet for data collection, the statistical analysis plan will be shared and the results will be published in a respective journal
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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.
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 Isotretinoin and Triple combination formula in people with Melasma, run by Zagazig 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagar Nofal, Dr. (+201006387707, hagarnofal@aucegypt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: three months). The study lists 2 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 NCT06201624, which also lists 3 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 11 Jan 2024.